Clinical Study of CBG131 CAR-T Cell Injection for the Treatment of CLDN18.2-Positive Advanced Gas… (NCT07394205) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Clinical Study of CBG131 CAR-T Cell Injection for the Treatment of CLDN18.2-Positive Advanced Gastric and Pancreatic Cancer
China18 participantsStarted 2026-09-30
Plain-language summary
The goal of this clinical trial is to learn if CBG131 works to treat advanced gastric cancer or pancreatic cancer in adults whose tumors are CLDN18.2-positive. It will also learn about the safety of CBG131 and find the best dose to use.
The main questions it aims to answer are:
Is CBG131 safe, and what medical problems do participants have when receiving it? Does CBG131 shrink tumors in participants with CLDN18.2-positive cancers? How long do the CAR-T cells stay and work in the body? Researchers will test different doses of CBG131 to see which dose is safest and most effective. This is an early-stage trial, so there is no placebo group-everyone who joins will receive the actual treatment.
Participants will:
Have their blood cells collected through a procedure called leukapheresis (so the CAR-T cells can be made).
Receive chemotherapy for 3 days to prepare their body for the CAR-T cells Get a single infusion of CBG131 CAR-T cells through an IV. Visit the clinic frequently for the first month, then regularly for 2 years for checkups, blood tests, and tumor assessments.
Keep track of their symptoms and any side effects they experience.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18-70 years (inclusive) at the time of informed consent; sex unrestricted.
. Voluntary participation: the subject (or legally authorized representative) must provide written informed consent (ICF, Informed Consent Form).
. Histologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma that has progressed after ≥ 2 prior systemic regimens, OR histologically confirmed advanced pancreatic adenocarcinoma that has progressed after ≥ 1 prior systemic regimen.
. CLDN18.2 positivity in archival or fresh tumor tissue by immunohistochemistry (IHC): ≥ 40% of tumor cells staining ≥ 2+.
. At least one measurable lesion per RECIST 1.1 (longest diameter ≥ 10 mm).
. Estimated life expectancy \> 12 weeks.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and Grading of Adverse Events (AEs) and Serious Adverse Events (SAEs)（Including CRS and ICANS）
Timeframe: From leukapheresis enrollment up to 15 years post-CBG131 infusion, or until study withdrawal, loss to follow-up, or death of the subject, whichever comes first.
2
Incidence and Determination of Dose-Limiting Toxicity (DLT) Related to CBG131
Timeframe: Within 28 days after CAR-T cell infusion.
3
Maximum Tolerated Dose (MTD) and Optimal Dosage of CBG131（Determined by 3+3 Dose-Escalation Schema）
Timeframe: Within 28 days after CAR-T cell infusion (DLT assessment period); the MTD is determined after completion of dose escalation for all cohorts.
Trial details
NCT IDNCT07394205
SponsorFirst Affiliated Hospital of Wenzhou Medical University
. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
. Adequate organ function within 14 days prior to leukapheresis, defined by all of the following:
Exclusion criteria
. Pregnant or lactating women.
. Active bacterial or fungal infection within 72 h before lymphodepletion. Subjects receiving prophylactic antibiotics, antifungals or antivirals are allowed if there is no evidence of active infection and the agents are not on the prohibited-medication list.
. Systemic corticosteroids equivalent to \> 15 mg/day prednisone within 2 weeks before leukapheresis (inhaled or topical steroids permitted). Any systemic glucocorticoids within 7 days before leukapheresis, except inhaled or topical preparations.
. Live-attenuated vaccine within 4 weeks before leukapheresis or planned during the study.
. Positive HBsAg or HBcAb with HBV-DNA ≥ ULN; positive HCV antibody with detectable HCV RNA; positive HIV antibody; positive syphilis serology.
. Prior hypersensitivity to immunotherapy, cyclophosphamide, fludarabine, albumin-bound paclitaxel, tocilizumab, or any component of CBG131 (e.g. DMSO), or other significant allergic history.
. Anti-cancer therapy within 2 weeks before leukapheresis (or 5 half-lives, whichever is shorter), including surgery, systemic chemotherapy, radiotherapy, interventional procedures, or anti-PD-1/PD-L1 monoclonal antibody (mAb)/Claudin18.2-targeted agents/other investigational drugs within 4 weeks (or 5 half-lives).