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

ConditionsAdenocarcinoma of GastricAdenocarcinoma of Esophagogastric Junction
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Immunochina Medical Science & Technology Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • IM96 CAR-T Cells

    Biological/Vaccine

    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.

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: IM96 CAR-T CellsExperimental treatment 1 intervention

Trial outcomes

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

Time frame
Up to 28 days after CAR-T cell infusion

Secondary outcomes

1

Objective remission rate (ORR)

Objective remission rate (ORR) after infusion

Time frame
At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion
2

Progression-free survival (PFS)

Progression-free survival (PFS) after infusion

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

Disease control rate (DCR)

Disease control rate (DCR) after infusion

Time frame
At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion
4

Duration of response (DOR)

Duration of response (DOR) after infusion

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Immunochina Medical Science & Technology Co., Ltd.

Lead sponsor

Peking University Cancer Hospital & Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: