Clinical Study of IM96 CAR-T Cell Therapy in Patients With Advanced Adenocarcinoma of Gastric/Esophagogastric Junction

NCT07406984 | Not Yet Recruiting Phase 1

• 1 other identifier: YMSZ9603
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Adenocarcinoma of Gastric; Adenocarcinoma of Esophagogastric Junction

Keywords

Advanced adenocarcinoma of gastric IM96 CAR-T; Advanced adenocarcinoma of esophagogastric junction IM96 CAR-T

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Related adverse events (AEs)

  Incidence of adverse events associated with IM96 CAR-T cell infusion within 28 days of IM96 CAR-T cell infusion,type, frequency, and severity of abnormal clinically significant vital signs, electrocardiograms, and laboratory tests examined, including dose-limiting toxicity

  Up to 28 days after CAR-T cell infusion

Secondary Outcomes (10)

• Objective remission rate (ORR)

  At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion

• Progression-free survival (PFS)

  At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion

• Disease control rate (DCR)

  At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion

• Duration of response (DOR)

  At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion

• Overall survival (OS)

  At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion

Study Arms (1)

IM96 CAR-T Cells

EXPERIMENTAL

After preconditioning with chemotherapy, IM96 CAR-T Cells will be evaluated

Biological: IM96 CAR-T Cells

Interventions

IM96 CAR-T Cells BIOLOGICAL

IM96 CAR-T Cells, 6×10\^8 CAR-T cells, 12×10\^8 CAR-T cells, 20×10\^8 CAR-T cells, treatment follows a lymphodepletion.Drug: Fludarabine Recommendation: 30 mg/m\^2 (D-5\~D- 3), determined by tumor burden at baseline.Drug: Fludarabine Recommendation: 30 mg/m\^2 (D-5\~D-3), determined by tumor burden at baseline.Drug:Cyclophosphamide Recommendation: 300mg/ m\^2 (D-5\~D-3), determined by tumor burden at baseline.

IM96 CAR-T Cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Notes:
• 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;
• Eastern cooperative oncology group (ECOG) score of 0-1;
• Women of childbearing potential who have a negative blood pregnancy test prior to the start of the trial and who agree to use effective contraception during the trial and up to the last follow-up visit;male patients whose partners are of childbearing potential agree to use effective contraception during the trial and up to the last follow-up visit;
• Laboratory tests should meet at least the indicators specified below:
• Hemoglobin (Hb) ≥ 80 g/L; Neutrophil count (Absolute neutrophil count, ANC) ≥ 1.5 x 10\^9/L; Platelet count (PLT) ≥ 75 x 10\^9/L; Absolute lymphocyte value ≥ 0.6 x 10\^9/L; Lymphocytes make up ≥10% of white blood cells; Creatinine clearance ≥60 ml/min; Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 x ULN and total bilirubin (TBL) ≤ 1.5 x ULN (for elevations of ALT and AST that can be explained by hepatic aggression, the high limits for AST and ALT can be adjusted upward to 5-fold, and the high limit for TBL may be adjusted upward to 3-fold; Serum albumin ≥ 3.0 g/dL; Prolongation of prothrombinogen time ≤ 4s;
• Left ventricular ejection fraction ≥ 50% with a normal ECG or an abnormal ECG that, in the judgment of the investigator, does not require treatment;
• Oxygen saturation \>92% in non-oxygenated state;

You may not qualify if:

• Presence of brain metastases;
• 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;
• 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;
• Received chemotherapeutic agents within 1 week prior to cell collection. Enrollment was allowed if the oral chemotherapeutic drug had passed at least 3 half-lives prior to cell collection;
• Those who used drugs to stimulate bone marrow hematopoietic cell production within 5 days prior to cell collection;
• Use of study drug within 4 weeks prior to cell collection.However, enrollment was allowed if the trial treatment was ineffective or the disease progressed during the trial and at least 5 half-lives had elapsed prior to cell collection;
• Received interventional therapy, radiotherapy, ablation, and other localized treatments for the study disease within 4 weeks prior to cell collection;
• Patients who have had major surgery or significant trauma within 4 weeks prior to cell collection or who are expected to require major surgery during the study period;
• Received targeted drug treatment such as apatinib or fuyiquatine within one week prior to cell collection;
• Received immunotherapy drugs such as anti-PD-1/PD-L1 within four weeks prior to cell collection;
• Prior treatment with anti-GUCY2C target (unless GUCY2C target test remains positive);

Sponsors & Collaborators

• Beijing Immunochina Medical Science & Technology Co., Ltd.: lead
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Study Officials

• Lin Shen, PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Wu

CONTACT

8615801390058; wufei@imunopharm.com

Lin Shen, PhD

CONTACT

8610 88196561; doctorshenlin@sina.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)