NCT06718738

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

A Phase I Clinical Study to Evaluate the Safety and Efficacy of IM96 CAR-T Cell Injection in Advanced Colorectal Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 colorectal cancer

Detailed description

This study is planned to enroll 6-12 patients with advanced colorectal cancer, using a modified "3+3" design for dose escalation, with two dose groups of 12×10\^8 CAR-T cells and 20×10\^8 CAR-T cells. 3-6 subjects are planned to be enrolled in each dose group to assess their safety, and if the incidence of horizontal dose-limiting toxicity (DLT) is ≤1/6 within 28 days after transfusion in one dose group, the next dose group can be started. If the incidence of horizontal dose-limiting toxicity (DLT) in a dose group is ≤1/6 within 28 days after transfusion, transfusion of cells from the next dose group can be initiated. This study will be divided into a screening period, a cell collection period, a chemotherapy pretreatment period, a return infusion and a follow-up period, and within 28 days of return infusion the investigator will assess whether a DLT (Dose limited toxicity) event has occurred to confirm the safety of this dose group.

Conditions

• Colorectal Cancer (CRC)

Interventions

Type	Name	Description
BIOLOGICAL	IM96 CAR-T Cells	IM96 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: 300 mg/ m\^2 (D-5\~D-3), determined by tumor burden at baseline.

Timeline

• Start date: 2024-12-15
• Primary completion: 2025-08-15
• Completion: 2026-08-15
• First posted: 2024-12-05
• Last updated: 2024-12-05

Locations

1 site across 1 country: China