Malignant TumorPhase 1NCT07567222
Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors
A Phase 1 study testing YMN101, YMN102 and YMN103 in people with Malignant Tumor, run by West China Hospital at 2 sites in China.
Trial summary
Advanced solid tumors remain a major therapeutic challenge due to their complex heterogeneity and the immunosuppressive tumor microenvironment (TME). Although cancer vaccines are designed to induce long-lasting antitumor immunity, their efficacy is often limited by the TME's immune-evasive mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Tumor
- What is being tested?
- YMN101, YMN102 and YMN103
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesChina
- Study dates
- 5 Jun 2026to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed advanced solid tumors, or radiologically diagnosed HCC, eligible for one of the following study parts based on tumor type, clinical status, and prior treatment history:
- Part A1: Patients with advanced osteosarcoma who achieved Stable Disease (SD) or Partial Response (PR) following first-line chemotherapy, and have at least one remaining lung metastatic lesion >= 0.5 cm.
- Part A2: Patients with advanced osteosarcoma who have relapsed, metastasized, or progressed following prior chemotherapy, or who are intolerant to the toxicities of previous systemic therapy.
- Part B1: Patients with advanced pancreatic cancer and disease progression following >= 1 prior line of standard systemic therapy.
- Part C1: Patients with advanced HNSCC and disease progression following >= 2 prior lines of systemic therapy.
- Part D1: Patients with advanced colon cancer and disease progression following >= 3 prior lines of therapy (including fluoropyrimidine, oxaliplatin, and irinotecan). Patients with RAS wild-type must have received EGFR inhibitors.
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- Part E1: Patients with advanced hepatocellular carcinoma (HCC) and disease progression following >= 2 prior lines of systemic therapy.
- Part F1: Patients with advanced glioma and disease progression following the first-line Stupp regimen.
- Part G1: Patients with advanced pancreatic cancer and disease progression following >= 1 prior line of therapy.
- Part H1: Patients with advanced or recurrent metastatic breast cancer who have progressed on or after >= 3 prior lines of systemic therapy.
- Age 18-75 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Life expectancy > 3 months.
- Adequate organ function within 7 days prior to first dose, including:
- Hematologic: Hemoglobin (Hb) >= 80 g/L; White Blood Cell count (WBC) >= 3.0 x 10^9/L; Platelet count (PLT) >= 80 x 10^9/L; Absolute Neutrophil Count (ANC) >= 1.5 x 10^9/L.
- Hepatic: Total bilirubin <= 1.5 x ULN (<= 3 x ULN for liver metastases or HCC); ALT and AST <= 2.5 x ULN (<= 5 x ULN for liver metastases or HCC).
- Renal: Creatinine clearance > 60 mL/min (Cockcroft-Gault formula). Coagulation: International Normalized Ratio (INR) <= 1.5 x ULN.
- At least one measurable or evaluable lesion per RECIST v1.1.
- Ability to understand and sign written informed consent and comply with study procedures.
Who cannot join
- Another primary malignancy within 5 years prior to first dose, except for adequately treated non-melanoma skin cancer, carcinoma in situ, or localized low-risk cancers.
- Active central nervous system (CNS) metastases or leptomeningeal disease.
- Positive for infectious diseases, including HIV, active Hepatitis C (HCV RNA positive), or active Hepatitis B (HBsAg or HBcAb positive with HBV DNA >= 500 IU/mL or >= 2000 copies/mL).
- Active pulmonary tuberculosis.
- Active autoimmune disease requiring systemic treatment within the past 2 years; or use of systemic corticosteroids (> 10 mg/day prednisone equivalent) within 4 weeks prior to first dose.
- Major surgery or significant trauma within 28 days prior to enrollment, or presence of unhealed wounds, ulcers, or conditions associated with high risk of bleeding or perforation.
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- Arterial/venous thrombosis or pulmonary embolism within 6 months, or CTCAE Grade >= 3 bleeding event within 28 days prior to treatment.
- Localized conditions at the injection site (e.g., infection, inflammation, or extensive scarring) or clinically significant coagulation disorders that contraindicate subcutaneous or intraosseous administration.
- Known hypersensitivity or intolerance to study treatment components or related compounds.
- Pregnant or breastfeeding, or planning to conceive (participant or partner) during the study.
- Any condition that, in the investigator's judgment, may compromise safety or interfere with study participation or evaluation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Xingchen Peng, Professor, 13458502834, pxx2014@163.com
Xingchen Peng, Professor
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Xingchen Peng, 13458502834, pxx2014@163.com
About this study
Official title: Safety, Tolerability, and Preliminary Antitumor Activity of Novel Therapeutic Tumor Vaccines in Advanced Solid Tumors
Advanced solid tumors remain a major therapeutic challenge due to their complex heterogeneity and the immunosuppressive tumor microenvironment (TME). Although cancer vaccines are designed to induce long-lasting antitumor immunity, their efficacy is often limited by the TME's immune-evasive mechanisms.
Building on this rationale, investigators developed a novel vaccine comprising irradiated tumor cells and stromal cells isolated from adjacent non-cancerous tissues or tumor tissues in combination with adjuvant. Irradiated tumor cells in vaccines such as YMN102, YMN103, YMN104, YMN105, YMN106, and YMN107 are transfected with GM-CSF; the others, such as YMN101 and YMN108, are not transfected with GM-CSF. Preclinical studies across multiple tumor models have demonstrated potent antitumor activity with no significant toxicity observed following administration. This first-in-human Phase I study is designed to evaluate the safety and tolerability of this irradiated vaccine in patients with advanced solid tumors, alongside a preliminary assessment of its antitumor activity and immunogenic profile.
Read more
This is a first-in-human, Phase I, open-label study designed to evaluate the safety and tolerability of this novel vaccine. The study includes multiple arms targeting specific malignancies, including osteosarcoma, pancreatic cancer, HNSCC, colorectal cancer, HCC, glioma, and TNBC.
The primary objective is to determine the incidence of dose-limiting toxicities (DLTs). Secondary objectives include assessing the objective response, progression-free survival (PFS), and overall survival (OS) per RECIST v1.1. Exploratory analyses will monitor dynamic changes in circulating biomarkers and intratumoral immune modulation to identify potential predictive markers of clinical response.
Read the detailed description
Whole tumor cell-based vaccines provide a broad spectrum of tumor-associated antigens; however, their clinical utility is frequently limited by low intrinsic immunogenicity and an inability to overcome the immunosuppressive tumor microenvironment (TME). These limitations underscore the urgent need for strategies that can simultaneously enhance antigen presentation and modulate TME-mediated immune evasion.
The TME plays a pivotal role in shaping antitumor immunity. Non-malignant cellular components within the TME not only contribute to immune regulation and tumor progression but also interact dynamically with tumor-associated antigens. Leveraging these interactions may offer a unique opportunity to potentiate immune activation and improve vaccine efficacy.
Building on this rationale, investigators developed a novel vaccine comprising irradiated tumor cells and stromal cells isolated from adjacent non-cancerous tissues or tumor tissues in combination with adjuvant. Irradiated tumor cells in vaccines such as YMN102, YMN103, YMN104, YMN105, YMN106, and YMN107 are transfected with GM-CSF; the others, such as YMN101 and YMN108, are not transfected with GM-CSF. Preclinical studies across multiple tumor models have demonstrated potent antitumor activity with no significant toxicities observed following administration. This first-in-human Phase I study is designed to evaluate the safety and tolerability of this irradiated vaccine in patients with advanced solid tumors, alongside a preliminary assessment of its antitumor activity and immunogenic profile.
- Conditions
- Malignant Tumor
- Being tested
- YMN101, YMN102, YMN103, YMN104, YMN105
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YMN101Biological
In the priming phase, subjects receive subcutaneous injections of the YMN101 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.
YMN102Biological
In the priming phase, subjects receive subcutaneous injections of the YMN102 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.
YMN103Biological
In the priming phase, subjects receive subcutaneous injections of the YMN103 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.
YMN104Biological
In the priming phase, subjects receive subcutaneous injections of the YMN104 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.
YMN105Biological
In the priming phase, subjects receive subcutaneous injections of the YMN105 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.
YMN106Biological
In the priming phase, subjects receive intracalvariosseous (ICO) injection of the YMN106 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.
YMN107Biological
In the priming phase, subjects receive subcutaneous injections of the YMN107 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.
YMN108Biological
In the priming phase, subjects receive subcutaneous injections of the YMN108 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.
RegorafenibDrug
Regorafenib at 160 mg once daily from Day 1 to Day 21, every 4 weeks (Q4W).
| Study group | Role | What they receive |
|---|---|---|
| Osteosarcoma: YMN101(Part A1) | Experimental | Participants will receive doses informed by the safety data and tolerability ranges established for analogous candidates in clinical studies. Patients with advanced osteosarcoma will be administered the vaccine via subcutaneous injection, with the immunization regimen consisting of a priming phase and a booster phase. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points per protocol. Receives: Biological: YMN101 |
| Pancreatic cancer: YMN102 (Part B1) | Experimental | Participants were assigned to different dose-level cohorts according to the order of enrollment, following a sequential escalation from low to high doses. Patients with advanced pancreatic cancer were administered the vaccine via subcutaneous injection, with the immunization regimen consisting of a priming phase and a booster phase. Dose escalation followed a standard 3+3 design to evaluate the safety and DLTs at each dose level. Participants received the assigned cell dose during the priming phase and completed subsequent administrations at predefined intervals according to the protocol. Receives: Biological: YMN102 |
| Head and neck squamous cell carcinoma: YMN103 (Part C1) | Experimental | Patients with advanced head and neck squamous cell carcinoma (HNSCC) will be vaccinated via subcutaneous injection. The immunization regimen encompasses a priming phase and subsequent booster phases. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points to evaluate the safety and tolerability. Receives: Biological: YMN103 |
| Colon cancer: YMN104 (Part D1) | Experimental | Patients with advanced colon cancer will be vaccinated via subcutaneous injection. The immunization regimen encompasses a priming phase and subsequent booster phases. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points to evaluate the safety and tolerability. Receives: Biological: YMN104 |
| Hepatocellular carcinoma: YMN105 (Part E1) | Experimental | Patients with advanced hepatocellular carcinoma (HCC) will be vaccinated via subcutaneous injection. The immunization regimen encompasses a priming phase and subsequent booster phases. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points to evaluate the safety and tolerability. Receives: Biological: YMN105 |
| Glioma: YMN106 (Part F1) | Experimental | Participants were assigned to different dose-level cohorts according to the order of enrollment, following a sequential escalation from low to high doses. Patients with advanced glioma received intracalvariosseous (ICO) injection of the vaccine. The immunization regimen consists of a priming phase and a booster phase. Dose escalation follows a standard 3+3 design to evaluate safety and DLTs at each dose level. Participants receive the assigned cell dose via intraosseous administration during the priming phase and complete subsequent administrations at predefined intervals according to the protocol. Receives: Biological: YMN106 |
| Pancreatic cancer: YMN107 (Part G1) | Experimental | Participants were assigned to different dose-level cohorts according to the order of enrollment, following a sequential escalation from low to high doses. Patients with advanced pancreatic cancer were administered the vaccine via subcutaneous injection, with the immunization regimen consisting of a priming phase and a booster phase. Dose escalation followed a standard 3+3 design to evaluate the safety and DLTs at each dose level. Participants received the assigned cell dose during the priming phase and completed subsequent administrations at predefined intervals according to the protocol. Receives: Biological: YMN107 |
| Breast cancer: YMN108 (Part H1) | Experimental | Participants were assigned to different dose-level cohorts according to the order of enrollment, following a sequential escalation from low to high doses. Patients with advanced or recurrent metastatic breast cancer were administered the vaccine via subcutaneous injection, with the immunization regimen consisting of a priming phase and a booster phase. Dose escalation followed a standard 3+3 design to evaluate the safety and DLTs at each dose level. Participants received the assigned cell dose during the priming phase and completed subsequent administrations at predefined intervals according to the protocol. Receives: Biological: YMN108 |
| Osteosarcoma: YMN101(Part A2) | Experimental | Participants will receive doses informed by the safety data and tolerability ranges established for analogous candidates in clinical studies. Patients with advanced osteosarcoma refractory to prior chemotherapy will be administered the vaccine via subcutaneous injection with concomitant regorafenib, following a priming-booster immunization regimen. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points per protocol. Receives: Biological: YMN101; Drug: Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
DLT is defined as any Treatment-Related Adverse Event (TRAE) or clinically significant laboratory abnormality occurring during the DLT observation period. TRAEs include events judged by the investigator to be "definitely," "probably," or "possibly" related to the study treatment. Severity will be graded according to NCI-CTCAE v5.0.
Measured: From the first dose up to 14 days following the third dose (Day 0 to approximately Day 42).
Number of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of the product was also an AE. The number of participants who experienced an AE was reported for each arm.
Measured: Up to 6 months from the date of the first dose.
Secondary outcomes (3)
Objective Response
Number of participants achieving a Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR) according to RECIST v1.1. Due to the small sample size, data will be reported as absolute counts.
Measured: Up to 6 months from the date of the first dose.
Progression-Free Survival
Progression-Free Survival (PFS) is defined as the time interval from the start of treatment until the first documented occurrence of disease progression (PD) according to RECIST v1.1, or death due to any cause, whichever occurs first.
Measured: Up to 6 months from the date of the first dose.
Overall Survival
OS is defined as the time interval from the start of treatment to death due to any cause. For participants who are still alive at the end of the study, data will be censored at the last known date of follow-up.
Measured: Up to 12 months from the date of the first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start5 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567222
- Sponsor's protocol ID
- 2025-2774
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song Z, Jiang Y, Zhang Y, Ao D, Ye C, Huang X, Zhou Y, Yang H, Xia R, Ai J, Wan D, Tong A, Wei Y, He X, Alu A, Wei X. Irradiated Liver Cancer Cell Vaccine Transfected With GM-CSF Induces Specific and Long-Lasting Anti-tumour Immunity Through the Synergistic Effect of Oxidised mtDNA and GM-CSF. Cell Prolif. 2026 Apr 8:e70198. doi: 10.1111/cpr.70198. Online ahead of print.
PubMed 41947668Wu F, Yang J, Liu J, Wang Y, Mu J, Zeng Q, Deng S, Zhou H. Signaling pathways in cancer-associated fibroblasts and targeted therapy for cancer. Signal Transduct Target Ther. 2021 Jun 10;6(1):218. doi: 10.1038/s41392-021-00641-0.
PubMed 34108441Jia H, Chen X, Zhang L, Chen M. Cancer associated fibroblasts in cancer development and therapy. J Hematol Oncol. 2025 Mar 28;18(1):36. doi: 10.1186/s13045-025-01688-0.
PubMed 40156055Saw PE, Chen J, Song E. Targeting CAFs to overcome anticancer therapeutic resistance. Trends Cancer. 2022 Jul;8(7):527-555. doi: 10.1016/j.trecan.2022.03.001. Epub 2022 Mar 21.
PubMed 35331673Lan T, Luo M, Wei X. Mesenchymal stem/stromal cells in cancer therapy. J Hematol Oncol. 2021 Nov 17;14(1):195. doi: 10.1186/s13045-021-01208-w.
PubMed 34789315Xu M, Zhang T, Xia R, Wei Y, Wei X. Targeting the tumor stroma for cancer therapy. Mol Cancer. 2022 Nov 2;21(1):208. doi: 10.1186/s12943-022-01670-1.
PubMed 36324128Senzer N, Barve M, Kuhn J, Melnyk A, Beitsch P, Lazar M, Lifshitz S, Magee M, Oh J, Mill SW, Bedell C, Higgs C, Kumar P, Yu Y, Norvell F, Phalon C, Taquet N, Rao DD, Wang Z, Jay CM, Pappen BO, Wallraven G, Brunicardi FC, Shanahan DM, Maples PB, Nemunaitis J. Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer. Mol Ther. 2012 Mar;20(3):679-86. doi: 10.1038/mt.2011.269. Epub 2011 Dec 20.
PubMed 22186789Tani K, Azuma M, Nakazaki Y, Oyaizu N, Hase H, Ohata J, Takahashi K, OiwaMonna M, Hanazawa K, Wakumoto Y, Kawai K, Noguchi M, Soda Y, Kunisaki R, Watari K, Takahashi S, Machida U, Satoh N, Tojo A, Maekawa T, Eriguchi M, Tomikawa S, Tahara H, Inoue Y, Yoshikawa H, Yamada Y, Iwamoto A, Hamada H, Yamashita N, Okumura K, Kakizoe T, Akaza H, Fujime M, Clift S, Ando D, Mulligan R, Asano S. Phase I study of autologous tumor vaccines transduced with the GM-CSF gene in four patients with stage IV renal cell cancer in Japan: clinical and immunological findings. Mol Ther. 2004 Oct;10(4):799-816. doi: 10.1016/j.ymthe.2004.07.001.
PubMed 15451464Zheng L, Ding D, Edil BH, Judkins C, Durham JN, Thomas DL 2nd, Bever KM, Mo G, Solt SE, Hoare JA, Bhattacharya R, Zhu Q, Osipov A, Onner B, Purtell KA, Cai H, Parkinson R, Hacker-Prietz A, Herman JM, Le DT, Azad NS, De Jesus-Acosta AMC, Blair AB, Kim V, Soares KC, Manos L, Cameron JL, Makary MA, Weiss MJ, Schulick RD, He J, Wolfgang CL, Thompson ED, Anders RA, Sugar E, Jaffee EM, Laheru DA. Vaccine-Induced Intratumoral Lymphoid Aggregates Correlate with Survival Following Treatment with a Neoadjuvant and Adjuvant Vaccine in Patients with Resectable Pancreatic Adenocarcinoma. Clin Cancer Res. 2021 Mar 1;27(5):1278-1286. doi: 10.1158/1078-0432.CCR-20-2974. Epub 2020 Dec 4.
PubMed 33277370Tian H, Shi G, Wang Q, Li Y, Yang Q, Li C, Yang G, Wu M, Xie Q, Zhang S, Yang Y, Xiang R, Yu D, Wei Y, Deng H. A novel cancer vaccine with the ability to simultaneously produce anti-PD-1 antibody and GM-CSF in cancer cells and enhance Th1-biased antitumor immunity. Signal Transduct Target Ther. 2016 Nov 18;1:16025. doi: 10.1038/sigtrans.2016.25. eCollection 2016.
PubMed 29263903Chen KS, Reinshagen C, Van Schaik TA, Rossignoli F, Borges P, Mendonca NC, Abdi R, Simon B, Reardon DA, Wakimoto H, Shah K. Bifunctional cancer cell-based vaccine concomitantly drives direct tumor killing and antitumor immunity. Sci Transl Med. 2023 Jan 4;15(677):eabo4778. doi: 10.1126/scitranslmed.abo4778. Epub 2023 Jan 4.
PubMed 36599004Frank MJ, Khodadoust MS, Czerwinski DK, Haabeth OAW, Chu MP, Miklos DB, Advani RH, Alizadeh AA, Gupta NK, Maeda LS, Reddy SA, Laport GG, Meyer EH, Negrin RS, Rezvani AR, Weng WK, Sheehan K, Faham M, Okada A, Moore AH, Phillips DL, Wapnir IL, Brody JD, Levy R. Autologous tumor cell vaccine induces antitumor T cell immune responses in patients with mantle cell lymphoma: A phase I/II trial. J Exp Med. 2020 Sep 7;217(9):e20191712. doi: 10.1084/jem.20191712.
PubMed 32558897Vermorken JB, Claessen AM, van Tinteren H, Gall HE, Ezinga R, Meijer S, Scheper RJ, Meijer CJ, Bloemena E, Ransom JH, Hanna MG Jr, Pinedo HM. Active specific immunotherapy for stage II and stage III human colon cancer: a randomised trial. Lancet. 1999 Jan 30;353(9150):345-50. doi: 10.1016/S0140-6736(98)07186-4.
PubMed 9950438Nemunaitis J. GVAX (GMCSF gene modified tumor vaccine) in advanced stage non small cell lung cancer. J Control Release. 2003 Aug 28;91(1-2):225-31. doi: 10.1016/s0168-3659(03)00210-4.
PubMed 12932654Mortara L, Frangione V, Castellani P, De Lerma Barbaro A, Accolla RS. Irradiated CIITA-positive mammary adenocarcinoma cells act as a potent anti-tumor-preventive vaccine by inducing tumor-specific CD4+ T cell priming and CD8+ T cell effector functions. Int Immunol. 2009 Jun;21(6):655-65. doi: 10.1093/intimm/dxp034. Epub 2009 Apr 24.
PubMed 19395374
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Preliminary Antitumor Activity of Novel Therapeutic Tumor Vaccines in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07567222
- Acronym / sponsor ID
- 2025-2774
- Conditions
- Malignant Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Advanced solid tumors remain a major therapeutic challenge due to their complex heterogeneity and the immunosuppressive tumor microenvironment (TME). Although cancer vaccines are designed to induce long-lasting antitumor immunity, their efficacy is often limited by the TME's immune-evasive mechanisms.
Building on this rationale, investigators developed a novel vaccine comprising irradiated tumor cells and stromal cells isolated from adjacent non-cancerous tissues or tumor tissues in combination with adjuvant. Irradiated tumor cells in vaccines such as YMN102, YMN103, YMN104, YMN105, YMN106, and YMN107 are transfected with GM-CSF; the others, such as YMN101 and YMN108, are not transfected with GM-CSF. Preclinical studies across multiple tumor models have demonstrated potent antitumor activity with no significant toxicity observed following administration. This first-in-human Phase I study is designed to evaluate the safety and tolerability of this irradiated vaccine in patients with advanced solid tumors, alongside a preliminary assessment of its antitumor activity and immunogenic profile.
This is a first-in-human, Phase I, open-label study designed to evaluate the safety and tolerability of this novel vaccine. The study includes multiple arms targeting specific malignancies, including osteosarcoma, pancreatic cancer, HNSCC, colorectal cancer, HCC, glioma, and TNBC.
The primary objective is to determine the incidence of dose-limiting toxicities (DLTs). Secondary objectives include assessing the objective response, progression-free survival (PFS), and overall survival (OS) per RECIST v1.1. Exploratory analyses will monitor dynamic changes in circulating biomarkers and intratumoral immune modulation to identify potential predictive markers of clinical response.
Detailed description
Whole tumor cell-based vaccines provide a broad spectrum of tumor-associated antigens; however, their clinical utility is frequently limited by low intrinsic immunogenicity and an inability to overcome the immunosuppressive tumor microenvironment (TME). These limitations underscore the urgent need for strategies that can simultaneously enhance antigen presentation and modulate TME-mediated immune evasion.
The TME plays a pivotal role in shaping antitumor immunity. Non-malignant cellular components within the TME not only contribute to immune regulation and tumor progression but also interact dynamically with tumor-associated antigens. Leveraging these interactions may offer a unique opportunity to potentiate immune activation and improve vaccine efficacy.
Building on this rationale, investigators developed a novel vaccine comprising irradiated tumor cells and stromal cells isolated from adjacent non-cancerous tissues or tumor tissues in combination with adjuvant. Irradiated tumor cells in vaccines such as YMN102, YMN103, YMN104, YMN105, YMN106, and YMN107 are transfected with GM-CSF; the others, such as YMN101 and YMN108, are not transfected with GM-CSF. Preclinical studies across multiple tumor models have demonstrated potent antitumor activity with no significant toxicities observed following administration. This first-in-human Phase I study is designed to evaluate the safety and tolerability of this irradiated vaccine in patients with advanced solid tumors, alongside a preliminary assessment of its antitumor activity and immunogenic profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Osteosarcoma: YMN101(Part A1) | Experimental | Biological: YMN101Participants will receive doses informed by the safety data and tolerability ranges established for analogous candidates in clinical studies. Patients with advanced osteosarcoma will be administered the vaccine via subcutaneous injection, with the immunization regimen consisting of a priming phase and a booster phase. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points per protocol. |
| Pancreatic cancer: YMN102 (Part B1) | Experimental | Biological: YMN102Participants were assigned to different dose-level cohorts according to the order of enrollment, following a sequential escalation from low to high doses. Patients with advanced pancreatic cancer were administered the vaccine via subcutaneous injection, with the immunization regimen consisting of a priming phase and a booster phase. Dose escalation followed a standard 3+3 design to evaluate the safety and DLTs at each dose level. Participants received the assigned cell dose during the priming phase and completed subsequent administrations at predefined intervals according to the protocol. |
| Head and neck squamous cell carcinoma: YMN103 (Part C1) | Experimental | Biological: YMN103Patients with advanced head and neck squamous cell carcinoma (HNSCC) will be vaccinated via subcutaneous injection. The immunization regimen encompasses a priming phase and subsequent booster phases. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points to evaluate the safety and tolerability. |
| Colon cancer: YMN104 (Part D1) | Experimental | Biological: YMN104Patients with advanced colon cancer will be vaccinated via subcutaneous injection. The immunization regimen encompasses a priming phase and subsequent booster phases. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points to evaluate the safety and tolerability. |
| Hepatocellular carcinoma: YMN105 (Part E1) | Experimental | Biological: YMN105Patients with advanced hepatocellular carcinoma (HCC) will be vaccinated via subcutaneous injection. The immunization regimen encompasses a priming phase and subsequent booster phases. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points to evaluate the safety and tolerability. |
| Glioma: YMN106 (Part F1) | Experimental | Biological: YMN106Participants were assigned to different dose-level cohorts according to the order of enrollment, following a sequential escalation from low to high doses. Patients with advanced glioma received intracalvariosseous (ICO) injection of the vaccine. The immunization regimen consists of a priming phase and a booster phase. Dose escalation follows a standard 3+3 design to evaluate safety and DLTs at each dose level. Participants receive the assigned cell dose via intraosseous administration during the priming phase and complete subsequent administrations at predefined intervals according to the protocol. |
| Pancreatic cancer: YMN107 (Part G1) | Experimental | Biological: YMN107Participants were assigned to different dose-level cohorts according to the order of enrollment, following a sequential escalation from low to high doses. Patients with advanced pancreatic cancer were administered the vaccine via subcutaneous injection, with the immunization regimen consisting of a priming phase and a booster phase. Dose escalation followed a standard 3+3 design to evaluate the safety and DLTs at each dose level. Participants received the assigned cell dose during the priming phase and completed subsequent administrations at predefined intervals according to the protocol. |
| Breast cancer: YMN108 (Part H1) | Experimental | Biological: YMN108Participants were assigned to different dose-level cohorts according to the order of enrollment, following a sequential escalation from low to high doses. Patients with advanced or recurrent metastatic breast cancer were administered the vaccine via subcutaneous injection, with the immunization regimen consisting of a priming phase and a booster phase. Dose escalation followed a standard 3+3 design to evaluate the safety and DLTs at each dose level. Participants received the assigned cell dose during the priming phase and completed subsequent administrations at predefined intervals according to the protocol. |
| Osteosarcoma: YMN101(Part A2) | Experimental | Biological: YMN101, Drug: RegorafenibParticipants will receive doses informed by the safety data and tolerability ranges established for analogous candidates in clinical studies. Patients with advanced osteosarcoma refractory to prior chemotherapy will be administered the vaccine via subcutaneous injection with concomitant regorafenib, following a priming-booster immunization regimen. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points per protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically or cytologically confirmed advanced solid tumors, or radiologically diagnosed HCC, eligible for one of the following study parts based on tumor type, clinical status, and prior treatment history:
- Part A1: Patients with advanced osteosarcoma who achieved Stable Disease (SD) or Partial Response (PR) following first-line chemotherapy, and have at least one remaining lung metastatic lesion >= 0.5 cm.
- Part A2: Patients with advanced osteosarcoma who have relapsed, metastasized, or progressed following prior chemotherapy, or who are intolerant to the toxicities of previous systemic therapy.
- Part B1: Patients with advanced pancreatic cancer and disease progression following >= 1 prior line of standard systemic therapy.
- Part C1: Patients with advanced HNSCC and disease progression following >= 2 prior lines of systemic therapy.
Key exclusion criteria (11 listed)
- Another primary malignancy within 5 years prior to first dose, except for adequately treated non-melanoma skin cancer, carcinoma in situ, or localized low-risk cancers.
- Active central nervous system (CNS) metastases or leptomeningeal disease.
- Positive for infectious diseases, including HIV, active Hepatitis C (HCV RNA positive), or active Hepatitis B (HBsAg or HBcAb positive with HBV DNA >= 500 IU/mL or >= 2000 copies/mL).
- Active pulmonary tuberculosis.
- Active autoimmune disease requiring systemic treatment within the past 2 years; or use of systemic corticosteroids (> 10 mg/day prednisone equivalent) within 4 weeks prior to first dose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YMN101In the priming phase, subjects receive subcutaneous injections of the YMN101 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion. | Biological | Osteosarcoma: YMN101(Part A1), Osteosarcoma: YMN101(Part A2) |
| YMN102In the priming phase, subjects receive subcutaneous injections of the YMN102 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion. | Biological | Pancreatic cancer: YMN102 (Part B1) |
| YMN103In the priming phase, subjects receive subcutaneous injections of the YMN103 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion. | Biological | Head and neck squamous cell carcinoma: YMN103 (Part C1) |
| YMN104In the priming phase, subjects receive subcutaneous injections of the YMN104 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion. | Biological | Colon cancer: YMN104 (Part D1) |
| YMN105In the priming phase, subjects receive subcutaneous injections of the YMN105 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion. | Biological | Hepatocellular carcinoma: YMN105 (Part E1) |
| YMN106In the priming phase, subjects receive intracalvariosseous (ICO) injection of the YMN106 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion. | Biological | Glioma: YMN106 (Part F1) |
| YMN107In the priming phase, subjects receive subcutaneous injections of the YMN107 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion. | Biological | Pancreatic cancer: YMN107 (Part G1) |
| YMN108In the priming phase, subjects receive subcutaneous injections of the YMN108 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion. | Biological | Breast cancer: YMN108 (Part H1) |
| RegorafenibRegorafenib at 160 mg once daily from Day 1 to Day 21, every 4 weeks (Q4W). | Drug | Osteosarcoma: YMN101(Part A2) |
Primary outcome
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time frame: From the first dose up to 14 days following the third dose (Day 0 to approximately Day 42).
DLT is defined as any Treatment-Related Adverse Event (TRAE) or clinically significant laboratory abnormality occurring during the DLT observation period. TRAEs include events judged by the investigator to be "definitely," "probably," or "possibly" related to the study treatment. Severity will be graded according to NCI-CTCAE v5.0.
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to 6 months from the date of the first dose.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of the product was also an AE. The number of participants who experienced an AE was reported for each arm.
3 secondary outcomes
Objective Response
Time frame: Up to 6 months from the date of the first dose.
Progression-Free Survival
Time frame: Up to 6 months from the date of the first dose.
Overall Survival
Time frame: Up to 12 months from the date of the first dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 41947668Song Z, Jiang Y, Zhang Y, Ao D, Ye C, Huang X, Zhou Y, Yang H, Xia R, Ai J, Wan D, Tong A, Wei Y, He X, Alu A, Wei X. Irradiated Liver Cancer Cell Vaccine Transfected With GM-CSF Induces Specific and Long-Lasting Anti-tumour Immunity Through the Synergistic Effect of Oxidised mtDNA and GM-CSF. Cell Prolif. 2026 Apr 8:e70198. doi: 10.1111/cpr.70198. Online ahead of print.
- Background: PubMed 34108441Wu F, Yang J, Liu J, Wang Y, Mu J, Zeng Q, Deng S, Zhou H. Signaling pathways in cancer-associated fibroblasts and targeted therapy for cancer. Signal Transduct Target Ther. 2021 Jun 10;6(1):218. doi: 10.1038/s41392-021-00641-0.
- Background: PubMed 40156055Jia H, Chen X, Zhang L, Chen M. Cancer associated fibroblasts in cancer development and therapy. J Hematol Oncol. 2025 Mar 28;18(1):36. doi: 10.1186/s13045-025-01688-0.
- Background: PubMed 35331673Saw PE, Chen J, Song E. Targeting CAFs to overcome anticancer therapeutic resistance. Trends Cancer. 2022 Jul;8(7):527-555. doi: 10.1016/j.trecan.2022.03.001. Epub 2022 Mar 21.
- Background: PubMed 34789315Lan T, Luo M, Wei X. Mesenchymal stem/stromal cells in cancer therapy. J Hematol Oncol. 2021 Nov 17;14(1):195. doi: 10.1186/s13045-021-01208-w.
- Background: PubMed 36324128Xu M, Zhang T, Xia R, Wei Y, Wei X. Targeting the tumor stroma for cancer therapy. Mol Cancer. 2022 Nov 2;21(1):208. doi: 10.1186/s12943-022-01670-1.
- Background: PubMed 22186789Senzer N, Barve M, Kuhn J, Melnyk A, Beitsch P, Lazar M, Lifshitz S, Magee M, Oh J, Mill SW, Bedell C, Higgs C, Kumar P, Yu Y, Norvell F, Phalon C, Taquet N, Rao DD, Wang Z, Jay CM, Pappen BO, Wallraven G, Brunicardi FC, Shanahan DM, Maples PB, Nemunaitis J. Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer. Mol Ther. 2012 Mar;20(3):679-86. doi: 10.1038/mt.2011.269. Epub 2011 Dec 20.
- Background: PubMed 15451464Tani K, Azuma M, Nakazaki Y, Oyaizu N, Hase H, Ohata J, Takahashi K, OiwaMonna M, Hanazawa K, Wakumoto Y, Kawai K, Noguchi M, Soda Y, Kunisaki R, Watari K, Takahashi S, Machida U, Satoh N, Tojo A, Maekawa T, Eriguchi M, Tomikawa S, Tahara H, Inoue Y, Yoshikawa H, Yamada Y, Iwamoto A, Hamada H, Yamashita N, Okumura K, Kakizoe T, Akaza H, Fujime M, Clift S, Ando D, Mulligan R, Asano S. Phase I study of autologous tumor vaccines transduced with the GM-CSF gene in four patients with stage IV renal cell cancer in Japan: clinical and immunological findings. Mol Ther. 2004 Oct;10(4):799-816. doi: 10.1016/j.ymthe.2004.07.001.
- Background: PubMed 33277370Zheng L, Ding D, Edil BH, Judkins C, Durham JN, Thomas DL 2nd, Bever KM, Mo G, Solt SE, Hoare JA, Bhattacharya R, Zhu Q, Osipov A, Onner B, Purtell KA, Cai H, Parkinson R, Hacker-Prietz A, Herman JM, Le DT, Azad NS, De Jesus-Acosta AMC, Blair AB, Kim V, Soares KC, Manos L, Cameron JL, Makary MA, Weiss MJ, Schulick RD, He J, Wolfgang CL, Thompson ED, Anders RA, Sugar E, Jaffee EM, Laheru DA. Vaccine-Induced Intratumoral Lymphoid Aggregates Correlate with Survival Following Treatment with a Neoadjuvant and Adjuvant Vaccine in Patients with Resectable Pancreatic Adenocarcinoma. Clin Cancer Res. 2021 Mar 1;27(5):1278-1286. doi: 10.1158/1078-0432.CCR-20-2974. Epub 2020 Dec 4.
- Background: PubMed 29263903Tian H, Shi G, Wang Q, Li Y, Yang Q, Li C, Yang G, Wu M, Xie Q, Zhang S, Yang Y, Xiang R, Yu D, Wei Y, Deng H. A novel cancer vaccine with the ability to simultaneously produce anti-PD-1 antibody and GM-CSF in cancer cells and enhance Th1-biased antitumor immunity. Signal Transduct Target Ther. 2016 Nov 18;1:16025. doi: 10.1038/sigtrans.2016.25. eCollection 2016.
- Background: PubMed 36599004Chen KS, Reinshagen C, Van Schaik TA, Rossignoli F, Borges P, Mendonca NC, Abdi R, Simon B, Reardon DA, Wakimoto H, Shah K. Bifunctional cancer cell-based vaccine concomitantly drives direct tumor killing and antitumor immunity. Sci Transl Med. 2023 Jan 4;15(677):eabo4778. doi: 10.1126/scitranslmed.abo4778. Epub 2023 Jan 4.
- Background: PubMed 32558897Frank MJ, Khodadoust MS, Czerwinski DK, Haabeth OAW, Chu MP, Miklos DB, Advani RH, Alizadeh AA, Gupta NK, Maeda LS, Reddy SA, Laport GG, Meyer EH, Negrin RS, Rezvani AR, Weng WK, Sheehan K, Faham M, Okada A, Moore AH, Phillips DL, Wapnir IL, Brody JD, Levy R. Autologous tumor cell vaccine induces antitumor T cell immune responses in patients with mantle cell lymphoma: A phase I/II trial. J Exp Med. 2020 Sep 7;217(9):e20191712. doi: 10.1084/jem.20191712.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YMN101, YMN102 and YMN103 in people with Malignant Tumor, run by West China Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingchen Peng, Professor (+86 18980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) (time frame: From the first dose up to 14 days following the third dose (Day 0 to approximately Day 42).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07567222, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.