Advanced Solid TumorPhase 1NCT05020119
Neoantigen-expanded Autologous Immune Cell Therapy
A Phase 1 study testing Neoantigen-expanded cell therapy. in people with Advanced Solid Tumor, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The investigators aim to investigate the patient's tumor neoantigen to generate "personalized cancer vaccine" and then to expand autologous dendritic cells-cytokine-induced killer cells (DC-CIK). The autologous DC-CIK will be cultured in vitro and re-infused into patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Neoantigen-expanded cell therapy.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Apr 2021to 30 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has one of the following solid tumors, including colorectal cancer, gastric cancer, pancreatic cancer, esophageal cancer, liver cancer, gastrointestinal stromal tumor, biliary tract cancer, kidney cancer, bladder cancer, prostate cancer, Head and neck cancer, nasopharyngeal cancer, skin cancer, melanoma, malignant sarcoma, breast cancer, ovarian cancer, cervical cancer, endometrial cancer, lung cancer, and brain cancer.
- The patient has at least one lesion that can be obtained by sectioning or cutting to identify somatic mutations from the tumor.
- The patient diagnosed as advanced solid tumor is refractory to standard treatment; or intolerable to or unsuitable for standard treatment.When evaluating to participate in the trial, the patient must still have solid tumor.
- All patients are refractory to approved standard treatment.The definition of standard treatment for different cancers is listed below.
- Patient with colorectal cancer must have received surgery or at least two prior chemotherapies, including oxaliplatin and irinotecan; or at least one of the target therapies for colorectal cancer, including Cetuximab, Bevacizumab, Panitumumab, etc.
- Patient with gastric cancer and pancreatic cancer must have received radiotherapy, surgery, or received chemotherapies.
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- Patient with esophageal cancer must have receivedthesecond-line systemic drug therapy (eg. chemotherapies or immunotherapies)
- Patient with liver cancer must havereceivedsurgery; radio-frequency ablation, or transcatheterial chemoembolization.
- Patient with biliary tract cancer must have refractory to the first-line treatment containing gemcitabine.
- Patient with gastrointestinal stromal tumors must have received the first-line target treatments.
- Patient with renal cancer must have received 2nd-line treatments (including chemotherapies or target therapies or combination with immunotherapies.
- Patient with bladder cancer must have received platinum-based chemotherapy or unable to receive chemotherapies and received immunotherapy.
- Patient with prostate cancer must have continued to disease progression or recur after receiving chemotherapies or the second-line hormone therapies.
- Patient with head and neck cancer and nasopharyngeal carcinoma must have received chemotherapies, including cetuximab or platinum.
- Patient with skin cancer and melanoma must have received at least one systemic treatment.
- If there is a genetic mutation for enrolled patients, the patient must be refractory to target therapies (related to mutation) or to the first-line chemotherapies.
- Patient with malignant sarcoma must have received first-line chemotherapies or target therapies.
- Patient with breast cancer who are unable to undergo surgery must have received anthracycline taxsnes and any third-line medication. If the patient with a positive ER gene, at least three third-line hormone therapies should be used. If patient with a positive HER2 gene, at least Hercrptin and Perjecta or T-DM1 should be used.
- Patient with ovarian cancer must have received platinum-containing chemotherapies to stop recurrence within 1-6 months; or have done more than the 2nd-line chemotherapies.
- Patient with cervical cancer must have received radiation therapy and chemotherapies.
- Patient with endometrial cancer must have received hormone therapy or radiotherapy.
- Patient with lung cancer must be refractory to the first-line standard treatment contained with platinum-based doublet chemotherapy in the patient without detected driver mutation or have failed to tyrosine kinase inhibitors and standard platinum-based doublet chemotherapy in those with drug related driver mutation.
- Patient with brain cancer must have received radiation therapy and chemotherapies; or patient's tumor still recurs within one to six months after chemotherapies, andcan not be completely resected; or patients have failed to target therapies.
- The patient who is willing to receive cell therapy.
- Age is greater than or equal to 20 years old.
- Clinical performance status of ECOG 0 or 1.
- Life expectancy exceeds six months
- Patients can take foods and drugs orally.
- Hematology:
- Absolute neutrophil count greater than 1000/mm3 without support of filgrastim
- Normal WBC (> 3000/mm3).
- Hemoglobin greater than 8.0 g/dl. Subjects may be transfused to reach this cut-off.
- Platelet count greater than 100,000/mm3
- Normal prothrombin time (less than or equal to 15.2 seconds)
- The heart, lung and liver function of the patient must comply with:
- NYHA (the New York Heart Association) Functional Class I or II
- Serum ALT / AST is less than 150 U/L (patients with advanced hepatocellular carcinoma need to be less than 180 U/L)
- Serum creatinine less than or equal to 1.6 mg/dl.
- Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert's Syndrome, who must have a total bilirubin less than or equal to 3 mg/dl.
- eGFR is greater than 60mL/min/1.73m2 (patients with advanced renal cell carcinoma need to be greater than 50 mL/min/1.73m2)
- Patient with primary major surgery needs to have elapsed ≥ 4 weeks prior to the planned first study treatment day.
- Patient who has ever received chemotherapy, radiotherapy or immunotherapy (anti-CTLA4 or anti-PD1/PDL1), or biologic therapy (anti-VEGF or anti-TKR) modalities need to washout ≥ 4 weeks prior to the baseline visit.
- Stop receiving systemic immunosuppressive drugs within 7 days before starting the immune cell infusion
- Willing to practice birth control during treatment
- Able to understand and sign the Informed Consent form
Who cannot join
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
- A systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders, cardiovascular disease, respiratory disease, immune system disease, myocardial infarction, cardiac arrhythmia, obstructive or restrictive pulmonary disease.
- Active tuberculosis (a history of tuberculosis exposure or a positive test for tuberculosis, including clinical, physical or imaging evidence).
- Acute or chronic infectious diseases (including: syphilis or human T lymphoblast infection) (In this trial, patients with HIV, HTLV, or syphilis infection are also excluded. HIV-positive patients may have lower immunity, resulting in lower response to treatment or the toxicity after treatment is more sensitive)
- Biliary or intestinal occlusion, cholangitis or severe gastrointestinal bleeding
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease [SCID] and acquired immune deficiency syndrome [AIDS]).
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- ≥ grade 4 major organ immune-related Adverse Events (irAEs) following treatment with immune checkpoint inhibitors.
- History of coronary revascularization or ischemic symptoms
- Documented left ventricular ejection fraction (LVEF) of less than or equal to 45% tested in patients with:
- Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block
- Age ≥ 60 years old
- A rapidly deteriorating disease that the trial investigators believe not be able to tolerate treatment or testing procedures
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333
Ming-Mo Hou, MD, +88633281200 ext. 8494, student871029@gmail.com
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Neoantigen-expanded Autologous Immune Cell Therapy for Solid Tumors
The investigators aim to investigate the patient's tumor neoantigen to generate "personalized cancer vaccine" and then to expand autologous dendritic cells-cytokine-induced killer cells (DC-CIK). The autologous DC-CIK will be cultured in vitro and re-infused into patients.
Read the detailed description
Cancer is the leading cause of death in the world. However, the response of traditional treatments(such as chemotherapy, radiotherapy, or target therapy) is yet limited. In this clinical trial study, the investigators will investigate the patient's tumor neoantigen to generate "personalized cancer vaccine" and then to expand autologous dendritic cells-cytokine-induced killer cells (DC-CIK). The autologous DC-CIK will be cultured in vitro and re-infused into patients. The similar clinical trial design and immune cell preparation have been recently published in international journals. Though adverse reactions (AE) have been reported, and there was no cases with severe adverse events (SAE), suggesting the safety of autologous immune cell therapy against cancers. The main propose of this clinical trial is to improve the treatment for solid tumors. By conducting this clinical trial, the investigators aim to enroll patients with refractory advanced solid tumors, and develop "neoantigen-expanded autologous immune cell therapy". The investigators will utilize "neoantigens" to expand the patients' autologous peripheral blood mononuclear cells into DC-CIK. The enrolled patients will receive autologous DC-CIK of 10 doses within 4~5 months of treatment, and the safety, tolerability, and efficacy of this immune cell therapy will be evaluated.
- Conditions
- Advanced Solid Tumor
- Being tested
- Neoantigen-expanded cell therapy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoantigen-expanded cell therapy.Drug
Also called Neoantigen-expanded autologous DC-CIK cells.
Infusion of personalized neoantigen-expanded T (CIK) cells
| Study group | Role | What they receive |
|---|---|---|
| Low dose of neoantigen-based cell therapy (N=3+3) | Experimental | (1±20%) × 109cells/200 mL every 14 days for 10 doses Receives: Drug: Neoantigen-expanded cell therapy. |
| Medium dose of neoantigen-based cell therapy (N=3+3) | Experimental | (3±20%) × 109cells/200 mL every 14 days for 10 doses Receives: Drug: Neoantigen-expanded cell therapy. |
| High dose of neoantigen-based cell therapy (N=3+3) | Experimental | (9±20%) ×109cells/400 mL every 14 days for 10 doses Receives: Drug: Neoantigen-expanded cell therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute, subacute toxicities and AEs of neoantigen-expanded autologous immune cell therapy.
Number of participants with ≥ grade 3 immune related Adverse Events (irAEs) as assessed by CTCAE v6.0.
Measured: Baseline to 20 weeks after cell infusion
Dose-limiting toxicity (DLT)
Determination of DLT to be made after receiving the second dose of cell product of each cohort.
Measured: Day 28
Maximum tolerated dose (MTD)
The dose where no DLT is observed among 3 consecutive participants, or no more than one DLT among 6 participants.
Measured: until Day 28
Secondary outcomes (1)
The antitumor activity of neoantigen-expanded autologous immune cell therapy
Number of participants with complete response and partial response, as s assessed by RECIST 1.1 and RANO.
Measured: every 6 weeks up to 24 weeks after cell infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start9 Apr 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Sequential
- Model description
- This study aims to investigate the safety profile and therapeutic potential of neoantigen-expanded autologous immune cell for treating solid tumors. The safety evaluation will be performed by a traditional 3+3 dose escalation scheme. The three cohorts will be established in the trial, and the dose level of each cohort will be enrolling 3\~6 subjects.
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HOU, MING-MO, Chang Gung Memorial Hospital
- Investigators
- Ming-Mo Hou, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020119
- Sponsor's protocol ID
- DC-CIK_TRIAL_PROPOSAL
- Status last verified
- Aug 2021
- First submitted
- 30 Jul 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zacharakis N, Chinnasamy H, Black M, Xu H, Lu YC, Zheng Z, Pasetto A, Langhan M, Shelton T, Prickett T, Gartner J, Jia L, Trebska-McGowan K, Somerville RP, Robbins PF, Rosenberg SA, Goff SL, Feldman SA. Immune recognition of somatic mutations leading to complete durable regression in metastatic breast cancer. Nat Med. 2018 Jun;24(6):724-730. doi: 10.1038/s41591-018-0040-8. Epub 2018 Jun 4.
PubMed 29867227Chen F, Zou Z, Du J, Su S, Shao J, Meng F, Yang J, Xu Q, Ding N, Yang Y, Liu Q, Wang Q, Sun Z, Zhou S, Du S, Wei J, Liu B. Neoantigen identification strategies enable personalized immunotherapy in refractory solid tumors. J Clin Invest. 2019 Mar 5;129(5):2056-2070. doi: 10.1172/JCI99538. Print 2019 May 1.
PubMed 30835255
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Neoantigen-expanded Autologous Immune Cell Therapy for Solid Tumors
- ClinicalTrials.gov ID
- NCT05020119
- Acronym / sponsor ID
- DC-CIK_TRIAL_PROPOSAL
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 25 Aug 2021 (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.
The investigators aim to investigate the patient's tumor neoantigen to generate "personalized cancer vaccine" and then to expand autologous dendritic cells-cytokine-induced killer cells (DC-CIK). The autologous DC-CIK will be cultured in vitro and re-infused into patients.
Detailed description
Cancer is the leading cause of death in the world. However, the response of traditional treatments(such as chemotherapy, radiotherapy, or target therapy) is yet limited. In this clinical trial study, the investigators will investigate the patient's tumor neoantigen to generate "personalized cancer vaccine" and then to expand autologous dendritic cells-cytokine-induced killer cells (DC-CIK). The autologous DC-CIK will be cultured in vitro and re-infused into patients. The similar clinical trial design and immune cell preparation have been recently published in international journals. Though adverse reactions (AE) have been reported, and there was no cases with severe adverse events (SAE), suggesting the safety of autologous immune cell therapy against cancers. The main propose of this clinical trial is to improve the treatment for solid tumors. By conducting this clinical trial, the investigators aim to enroll patients with refractory advanced solid tumors, and develop "neoantigen-expanded autologous immune cell therapy". The investigators will utilize "neoantigens" to expand the patients' autologous peripheral blood mononuclear cells into DC-CIK. The enrolled patients will receive autologous DC-CIK of 10 doses within 4~5 months of treatment, and the safety, tolerability, and efficacy of this immune cell therapy will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study aims to investigate the safety profile and therapeutic potential of neoantigen-expanded autologous immune cell for treating solid tumors. The safety evaluation will be performed by a traditional 3+3 dose escalation scheme. The three cohorts will be established in the trial, and the dose level of each cohort will be enrolling 3~6 subjects.
| Arm | Type | Receives |
|---|---|---|
| Low dose of neoantigen-based cell therapy (N=3+3) | Experimental | Drug: Neoantigen-expanded cell therapy.(1±20%) × 109cells/200 mL every 14 days for 10 doses |
| Medium dose of neoantigen-based cell therapy (N=3+3) | Experimental | Drug: Neoantigen-expanded cell therapy.(3±20%) × 109cells/200 mL every 14 days for 10 doses |
| High dose of neoantigen-based cell therapy (N=3+3) | Experimental | Drug: Neoantigen-expanded cell therapy.(9±20%) ×109cells/400 mL every 14 days for 10 doses |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (45 listed)
- The patient has one of the following solid tumors, including colorectal cancer, gastric cancer, pancreatic cancer, esophageal cancer, liver cancer, gastrointestinal stromal tumor, biliary tract cancer, kidney cancer, bladder cancer, prostate cancer, Head and neck cancer, nasopharyngeal cancer, skin cancer, melanoma, malignant sarcoma, breast cancer, ovarian cancer, cervical cancer, endometrial cancer, lung cancer, and brain cancer.
- The patient has at least one lesion that can be obtained by sectioning or cutting to identify somatic mutations from the tumor.
- The patient diagnosed as advanced solid tumor is refractory to standard treatment; or intolerable to or unsuitable for standard treatment.When evaluating to participate in the trial, the patient must still have solid tumor.
- All patients are refractory to approved standard treatment.The definition of standard treatment for different cancers is listed below.
- If there is a genetic mutation for enrolled patients, the patient must be refractory to target therapies (related to mutation) or to the first-line chemotherapies.
Key exclusion criteria (12 listed)
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
- A systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders, cardiovascular disease, respiratory disease, immune system disease, myocardial infarction, cardiac arrhythmia, obstructive or restrictive pulmonary disease.
- Active tuberculosis (a history of tuberculosis exposure or a positive test for tuberculosis, including clinical, physical or imaging evidence).
- Acute or chronic infectious diseases (including: syphilis or human T lymphoblast infection) (In this trial, patients with HIV, HTLV, or syphilis infection are also excluded. HIV-positive patients may have lower immunity, resulting in lower response to treatment or the toxicity after treatment is more sensitive)
- Biliary or intestinal occlusion, cholangitis or severe gastrointestinal bleeding
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 |
|---|---|---|
| Neoantigen-expanded cell therapy.Also: Neoantigen-expanded autologous DC-CIK cells.Infusion of personalized neoantigen-expanded T (CIK) cells | Drug | High dose of neoantigen-based cell therapy (N=3+3), Low dose of neoantigen-based cell therapy (N=3+3), Medium dose of neoantigen-based cell therapy (N=3+3) |
Primary outcome
Acute, subacute toxicities and AEs of neoantigen-expanded autologous immune cell therapy.
Time frame: Baseline to 20 weeks after cell infusion
Number of participants with ≥ grade 3 immune related Adverse Events (irAEs) as assessed by CTCAE v6.0.
Dose-limiting toxicity (DLT)
Time frame: Day 28
Determination of DLT to be made after receiving the second dose of cell product of each cohort.
Maximum tolerated dose (MTD)
Time frame: until Day 28
The dose where no DLT is observed among 3 consecutive participants, or no more than one DLT among 6 participants.
1 secondary outcome
The antitumor activity of neoantigen-expanded autologous immune cell therapy
Time frame: every 6 weeks up to 24 weeks after cell infusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Background: PubMed 29867227Zacharakis N, Chinnasamy H, Black M, Xu H, Lu YC, Zheng Z, Pasetto A, Langhan M, Shelton T, Prickett T, Gartner J, Jia L, Trebska-McGowan K, Somerville RP, Robbins PF, Rosenberg SA, Goff SL, Feldman SA. Immune recognition of somatic mutations leading to complete durable regression in metastatic breast cancer. Nat Med. 2018 Jun;24(6):724-730. doi: 10.1038/s41591-018-0040-8. Epub 2018 Jun 4.
- Background: PubMed 30835255Chen F, Zou Z, Du J, Su S, Shao J, Meng F, Yang J, Xu Q, Ding N, Yang Y, Liu Q, Wang Q, Sun Z, Zhou S, Du S, Wei J, Liu B. Neoantigen identification strategies enable personalized immunotherapy in refractory solid tumors. J Clin Invest. 2019 Mar 5;129(5):2056-2070. doi: 10.1172/JCI99538. Print 2019 May 1.
- The protocol of this study is referenced by Zacharakis N et al. study.Link provided by the sponsor.
- The protocol of this study is referenced by Chen F et al. study.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ming-Mo Hou, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neoantigen-expanded cell therapy. in people with Advanced Solid Tumor, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 45 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuang-Wei Wang, PhD (+88633281200 ext. 8494, kiruamairo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute, subacute toxicities and AEs of neoantigen-expanded autologous immune cell therapy. (time frame: Baseline to 20 weeks after cell infusion). The study lists 3 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 NCT05020119, which also lists 2 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 25 Aug 2021.