Clinical Study of IM96 CAR-T Cell Therapy in Patients With Advanced Colorectal Cancer

Trial statusRecruiting
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 colorectal cancer

Eligibility criteria

Qualifiers

The age is 18 to 75 years (including boundary values) and the gender is not limited;

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 Colorectal and Gastric Cancer, 2024 Edition;

Hemoglobin (Hb) ≥ 90 g/L;

Neutrophil count (Absolute neutrophil count, ANC) ≥ 1.5 x 10^9/L;

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

Treatments tested in this trial

  • IM96 CAR-T Cells

Treatment groups

9 Participants
are divided into 1 treatment group

Sponsors and collaborators

Beijing Immunochina Medical Science & Technology Co., Ltd.

Lead sponsor

Peking University Cancer Hospital & Institute

Collaborator