Gastrointestinal CancerPhase 1NCT07329894
Safety, Tolerance and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastrointestinal Cancer
A Phase 1 study testing XH001 injection and Tumor vaccine-induced specific T-cell injection in people with Gastrointestinal Cancer, run by Beijing GoBroad Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn the safety of tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell in treating advanced gastrointestinal cancer in adults. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- XH001 injection and Tumor vaccine-induced specific T-cell injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to Oct 2029
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Aged between 18 and 70 years old, male or female.
- Advanced gastrointestinal cancer that has been diagnosed by histological and/or cellular pathology, and which has failed to respond to second-line standard treatment or is intolerant to it, or is not suitable for standard treatment at this stage.
- According to the RECIST 1.1 criteria for evaluating the efficacy of solid tumors, there must be at least one measurable lesion as the target lesion for efficacy evaluation. The total diameter of the overall tumor lesion (excluding bone metastases) should be ≤ 100mm, and the diameter of a single tumor lesion should be ≤ 30mm. If the lesion that has received local treatment (radiotherapy, ablation, vascular intervention, etc.) is the only lesion, then there must be clear imaging evidence of disease progression for this lesion.
- Expected survival duration ≥ 12 weeks.
- Adequate organ and bone marrow function.
Who cannot join
- Requires long-term systemic administration of antiallergic drugs, or has severe hypersensitivity reactions (≥Grade 3) to XH001 injection and/or any of its excipients.
- Central nervous system metastases with symptoms, and/or meningeal metastases.
- Having received immunomodulatory drug therapy within 2 weeks prior to the first administration day (D1) of XH001 injection.
- Suffer from skin diseases that may prevent the intradermal injection from reaching the target area (such as psoriasis).
- Subjects with toxic side effects from previous treatment that have not recovered to CTCAE grade≤2, excluding hair loss.
- Subjects who received systemic steroid treatment (daily dose exceeding 10mg of prednisone equivalent) or any other form of immunosuppressive treatment within 7 days before the first administration of XH001 injection, excluding:1) Intranasal inhalation of local steroids or local steroid injection (such as intra-articular injection); 2) Systemic corticosteroid treatment not exceeding 10mg/day of prednisone or its equivalent physiological dose.
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- Subjects who have previously received therapeutic tumor vaccines or therapeutic cell therapy products.
- Previously received allogeneic hematopoietic stem cell or allogeneic bone marrow transplantation, or previously received solid organ transplantation, or currently using immunosuppressive drugs.
- Have active or poorly controlled severe infections during screening period.
- Virological tests show positive for human immunodeficiency virus antibodies, hepatitis B surface antigen and/or hepatitis B core antibody with hepatitis B virus DNA > 1000 IU/ml, positive for hepatitis C virus antibodies, and positive for Treponema pallidum specific antibodies.
- Patients with other malignancies within 5 years before enrollment, except for those with a history of appropriately treated and cured cervical carcinoma in situ, breast carcinoma in situ, or skin basal cell carcinoma.
- Any history of autoimmune diseases.
- Known to have active pulmonary tuberculosis (TB).
- Patients who have received systemic chemotherapy, radiotherapy, molecular targeted therapy, biological immunotherapy, hormone therapy or unapproved clinical trial drugs/instruments within 2 weeks before screening.
- Subjects who are still participating in other clinical trials during the screening period.
- Pregnant or lactating women.
- Other severe, acute, or chronic medical or psychiatric conditions, or laboratory abnormalities, that, to the investigator's discretion, may increase the risks of participating in the trial or may interfere with the interpretation of the trial results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Gobroad Hospital
Beijing
Changsong Qi, 0086-15143214682, xiwangpku@126.com
About this study
Official title: A Single-center, Non-randomized, Open-label Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastrointestinal Cancer
The goal of this clinical trial is to learn the safety of tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell in treating advanced gastrointestinal cancer in adults. It will also learn if the combined treatment works to treat advanced gastrointestinal cancer.The main questions it aims to answer are:What medical problems do participants have when using the combined treatment? Does tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell eliminate or shrink the tumor, and can it prolong the patient's survival period?
- Conditions
- Gastrointestinal Cancer
- Being tested
- XH001 injection, Tumor vaccine-induced specific T-cell injection
- Keywords
- Tumor Neoantigen Vaccine, Gastrointestinal Cancer, Adoptive Cell Therapy
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XH001 injectionDrug
mRNA tumor neoantigen vaccine
Tumor vaccine-induced specific T-cell injectionDrug
Adoptive T Cell Therapy
| Study group | Role | What they receive |
|---|---|---|
| Tumor neoantigen vaccine and tumor vaccine-induced specific T-cell Arm 1 | Experimental | Tumor neoantigen vaccine; Tumor vaccine-induced specific T-cell Dose 1 Receives: Drug: XH001 injection; Drug: Tumor vaccine-induced specific T-cell injection |
| Tumor neoantigen vaccine and tumor vaccine induced specific T-cell Arm 2 | Experimental | Tumor neoantigen vaccine; Tumor vaccine induced specific T-cell dose 2 Receives: Drug: XH001 injection; Drug: Tumor vaccine-induced specific T-cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Incidence and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE] V5.0
Measured: 12 months
Dose Limiting Toxicity
Safety events occurring within 28 days after the reinfusion of neoantigen vaccine-induced tumor-specific T cells and related to this cell therapy.
Measured: From reinfusion of neoantigen vaccine-induced tumor-specific T cells to 28 days after the reinfusion
Secondary outcomes (6)
ORR
Objective Response Rate
Measured: 24 months
PFS
Progression-Free Survival
Measured: 24 months
DCR
Disease Control Rate
Measured: 24 months
OS
Overall Survival
Measured: 36 months
BOR
Best Overall Response
Measured: 24 months
DOR
Duration of Response
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancerStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NeoCura
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329894
- Sponsor's protocol ID
- XKY-C-007
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rojas LA, Sethna Z, Soares KC, Olcese C, Pang N, Patterson E, Lihm J, Ceglia N, Guasp P, Chu A, Yu R, Chandra AK, Waters T, Ruan J, Amisaki M, Zebboudj A, Odgerel Z, Payne G, Derhovanessian E, Muller F, Rhee I, Yadav M, Dobrin A, Sadelain M, Luksza M, Cohen N, Tang L, Basturk O, Gonen M, Katz S, Do RK, Epstein AS, Momtaz P, Park W, Sugarman R, Varghese AM, Won E, Desai A, Wei AC, D'Angelica MI, Kingham TP, Mellman I, Merghoub T, Wolchok JD, Sahin U, Tureci O, Greenbaum BD, Jarnagin WR, Drebin J, O'Reilly EM, Balachandran VP. Personalized RNA neoantigen vaccines stimulate T cells in pancreatic cancer. Nature. 2023 Jun;618(7963):144-150. doi: 10.1038/s41586-023-06063-y. Epub 2023 May 10.
PubMed 37165196
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Non-randomized, Open-label Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT07329894
- Acronym / sponsor ID
- XKY-C-007
- Conditions
- Gastrointestinal Cancer
- Keywords
- Tumor Neoantigen Vaccine, Gastrointestinal Cancer, Adoptive Cell Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Collaborators
- NeoCura
- Study start
- Feb 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 9 Jan 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.
The goal of this clinical trial is to learn the safety of tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell in treating advanced gastrointestinal cancer in adults. It will also learn if the combined treatment works to treat advanced gastrointestinal cancer.The main questions it aims to answer are:What medical problems do participants have when using the combined treatment? Does tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell eliminate or shrink the tumor, and can it prolong the patient's survival period?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tumor neoantigen vaccine and tumor vaccine-induced specific T-cell Arm 1 | Experimental | Drug: XH001 injection, Drug: Tumor vaccine-induced specific T-cell injectionTumor neoantigen vaccine; Tumor vaccine-induced specific T-cell Dose 1 |
| Tumor neoantigen vaccine and tumor vaccine induced specific T-cell Arm 2 | Experimental | Drug: XH001 injection, Drug: Tumor vaccine-induced specific T-cell injectionTumor neoantigen vaccine; Tumor vaccine induced specific T-cell dose 2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form.
- Aged between 18 and 70 years old, male or female.
- Advanced gastrointestinal cancer that has been diagnosed by histological and/or cellular pathology, and which has failed to respond to second-line standard treatment or is intolerant to it, or is not suitable for standard treatment at this stage.
- According to the RECIST 1.1 criteria for evaluating the efficacy of solid tumors, there must be at least one measurable lesion as the target lesion for efficacy evaluation. The total diameter of the overall tumor lesion (excluding bone metastases) should be ≤ 100mm, and the diameter of a single tumor lesion should be ≤ 30mm. If the lesion that has received local treatment (radiotherapy, ablation, vascular intervention, etc.) is the only lesion, then there must be clear imaging evidence of disease progression for this lesion.
- Expected survival duration ≥ 12 weeks.
Key exclusion criteria (17 listed)
- Requires long-term systemic administration of antiallergic drugs, or has severe hypersensitivity reactions (≥Grade 3) to XH001 injection and/or any of its excipients.
- Central nervous system metastases with symptoms, and/or meningeal metastases.
- Having received immunomodulatory drug therapy within 2 weeks prior to the first administration day (D1) of XH001 injection.
- Suffer from skin diseases that may prevent the intradermal injection from reaching the target area (such as psoriasis).
- Subjects with toxic side effects from previous treatment that have not recovered to CTCAE grade≤2, excluding hair loss.
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 |
|---|---|---|
| XH001 injectionmRNA tumor neoantigen vaccine | Drug | Tumor neoantigen vaccine and tumor vaccine induced specific T-cell Arm 2, Tumor neoantigen vaccine and tumor vaccine-induced specific T-cell Arm 1 |
| Tumor vaccine-induced specific T-cell injectionAdoptive T Cell Therapy | Drug | Tumor neoantigen vaccine and tumor vaccine induced specific T-cell Arm 2, Tumor neoantigen vaccine and tumor vaccine-induced specific T-cell Arm 1 |
Primary outcome
Adverse event
Time frame: 12 months
Incidence and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE] V5.0
Dose Limiting Toxicity
Time frame: From reinfusion of neoantigen vaccine-induced tumor-specific T cells to 28 days after the reinfusion
Safety events occurring within 28 days after the reinfusion of neoantigen vaccine-induced tumor-specific T cells and related to this cell therapy.
6 secondary outcomes
ORR
Time frame: 24 months
PFS
Time frame: 24 months
DCR
Time frame: 24 months
OS
Time frame: 36 months
BOR
Time frame: 24 months
DOR
Time frame: 24 months
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 12 Feb 2026.
- Background: PubMed 37165196Rojas LA, Sethna Z, Soares KC, Olcese C, Pang N, Patterson E, Lihm J, Ceglia N, Guasp P, Chu A, Yu R, Chandra AK, Waters T, Ruan J, Amisaki M, Zebboudj A, Odgerel Z, Payne G, Derhovanessian E, Muller F, Rhee I, Yadav M, Dobrin A, Sadelain M, Luksza M, Cohen N, Tang L, Basturk O, Gonen M, Katz S, Do RK, Epstein AS, Momtaz P, Park W, Sugarman R, Varghese AM, Won E, Desai A, Wei AC, D'Angelica MI, Kingham TP, Mellman I, Merghoub T, Wolchok JD, Sahin U, Tureci O, Greenbaum BD, Jarnagin WR, Drebin J, O'Reilly EM, Balachandran VP. Personalized RNA neoantigen vaccines stimulate T cells in pancreatic cancer. Nature. 2023 Jun;618(7963):144-150. doi: 10.1038/s41586-023-06063-y. Epub 2023 May 10.
- 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.
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 XH001 injection and Tumor vaccine-induced specific T-cell injection in people with Gastrointestinal Cancer, run by Beijing GoBroad Hospital at 1 site 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 6 inclusion and 17 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 12 Feb 2026. 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 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 Changsong Qi, MD (0086-15143214682, xiwangpku@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: 12 months). 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 NCT07329894, which also lists 1 linked publication.
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 12 Feb 2026.