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

Starting soon · Phase 1

Conditions studied: Adenocarcinoma of Gastric, Adenocarcinoma of Esophagogastric Junction

In brief

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

Key facts

Study ID

NCT07406984

Run by

Beijing Immunochina Medical Science & Technology Co., Ltd.

People needed

18

Starts

2026-03-05

Expected to finish

2027-12-31

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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;
• Vascular access is adequate for cell collection, and lines are available for patients with existing central venous catheters;
• Those who voluntarily participate in the trial and sign the informed consent form.

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;
• 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;
• 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);
• Those who have received other cell therapy or genetically modified cell therapy in the past, such as TCR-T therapy, CAR-T therapy, etc;
• Prior or clinically significant CNS disorders at screening, such as epilepsy, epileptic seizures, cerebrovascular disease (ischemia/hemorrhage/cerebral infarction), cerebral edema, reversible posterior leukoencephalopathy, paralysis, aphasia, stroke, severe brain injury,dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or psychiatric disorders;
• Chronic or active infection requiring systemic therapy and history of symptomatic viral infection that has not been completely cured. For example, Hepatitis B: patients who are positive for Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) and whose peripheral blood HBV-DNA test is above the lower limit of detection;patients who are positive for Hepatitis C Virus Antibody (HCVAb) and whose peripheral blood HCV-RNA test is above the lower limit of detection; and patients infected with Human Immunodeficiency Virus (HIV), Syphilis;
• Active EBV and cytomegalovirus, defined as patients with IgM antibodypositive or IgM antibody-negative but higher-than-normal EBV-DNA in EBV serum; and cytomegalovirus (CMV) seropositive or IgM antibodynegative but higher-than-normal CMV-DNA in serum;
• Vaccination with live vaccine within 6 weeks prior to the start of screening;
• Abnormalities of cardiac function include: long QTc syndrome or QTc interval >480 ms; complete left bundle branch block, degree II/III AV block; severe, uncontrolled arrhythmias requiring pharmacologic therapy; history of chronic congestive heart failure with NYHA class ≥3 (refer to Attachment 3) with a cardiac ejection fraction of less than 50% in the 6 months prior to screening; CTC AE ≥3 grade heart valve disease;myocardial infarction, cardiac angioplasty or stenting,unstable angina, history of severe pericardial disease, or other clinically significant cardiac disease within 6 months prior to screening;
• Patients requiring anticoagulation therapy;
• Requires long-term use of medications that can affect clotting (e.g.,aspirin, warfarin, etc.);
• History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to initiation of screening;

Where it is running

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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