Clinical Study of IM96 CAR-T Cell Therapy in Patients With Advanced Adenocarcinoma of Gastric/Eso… (NCT07406984) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Clinical Study of IM96 CAR-T Cell Therapy in Patients With Advanced Adenocarcinoma of Gastric/Esophagogastric Junction
China18 participantsStarted 2026-03-05
Plain-language summary
This study, a single-center, open, single-dose clinical study, was designed to evaluate the safety and efficacy of IM96 CAR-T cells in treating patients with advanced adenocarcinoma of gastric/esophagogastric junction
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. The age is 18 to 75 years (including boundary values) and the gender is not limited;
✓. Patients with advanced locally inoperable or metastatic adenocarcinoma of the stomach/gastric esophageal junction diagnosed by pathohistology;
✓. Patients with metastatic stomach/gastric esophageal junction who have failed or are intolerant to standard therapy;
✓. The standardized systemic treatment received by the patient must be in accordance with the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Treatment of Gastric Cancer, 2025 Edition;
✓. The standard prior treatment regimen should incorporate therapeutic strategies guided by relevant molecular biomarkers. Specifically, patients with HER2-positive tumors must have received HER2-targeted therapy;
✓. Claims of treatment intolerance: Patients who are unable to continue current effective systemic standardized treatment due to toxic side effects such as grade ≥3 vomiting, diarrhea, abdominal pain, bone marrow suppression, etc., and who do not accept refusal for financial and personal reasons;
✓. Presence of at least one measurable lesion that meets RECIST 1.1 criteria;
✓. Patients must provide a tumor sample within 2 years that meets the requirements (paraffin block or number of unstained sections that meet the testing requirements set by the Institute) that is positive for GUCY2C expression by immunohistochemistry;
Exclusion criteria
✕. Presence of brain metastases;
What they're measuring
1
Incidence of Treatment Related adverse events (AEs)
Timeframe: Up to 28 days after CAR-T cell infusion
Trial details
NCT IDNCT07406984
SponsorBeijing Immunochina Medical Science & Technology Co., Ltd.
. Patients who have previously received or are awaiting an organ transplant;
✕. Toxicity due to prior therapy not stabilized or recovered to ≤ grade 1 (except in cases judged by the investigator to be not clinically significant);
✕. Plasmapheresis (e.g., pleural effusion, abdominal effusion, pericardial effusion) with symptoms of compression that cannot be controlled with treatment;
✕. Autoimmune disease requiring systemic immunosuppressive therapy (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) within 2 years prior to the start of screening;
✕. Lung diseases that the inversgaters determined were not suitable for inclusion in the study;
✕. Use of any of the following medications or treatments during the designated time period prior to cell collection:
✕. Therapeutic doses of corticosteroids have been used within 7 days prior to cell collection. However, topical and inhaled steroids are permitted;