Study on the Safety and Tolerability of PD-1 Knockout Tumor-infiltrating T Cells (TILs) in the Treatment of Advanced Colorectal Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

December 31, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Colorectal Cancer (CRC)Tumor Infiltrating LymphocytesPD-1
Interventions
BIOLOGICAL

transfusion of 5×10^8 PD-1 knockout TILs per kg body weight

Obtaining individual tumor tissue via surgery resection or biopsy, and then isolating TILs in the tumor under GMP conditions, and further using gene editing technology to knockout PD-1 to finally obtain gene-edited TILs-T cells, and transfusing them back to the patient.

BIOLOGICAL

transfusion of 1×10^9 PD-1 edited TILs per kg body weight

Obtaining individual tumor tissue via surgery resection or biopsy, and then isolating TILs in the tumor under GMP conditions, and further using gene editing technology to knockout PD-1 to finally obtain gene-edited TILs-T cells, and transfusing them back to the patient.

BIOLOGICAL

transfusion of 2×10^9 PD-1 edited TILs per kg body weight

Obtaining individual tumor tissue via surgery resection or biopsy, and then isolating TILs in the tumor under GMP conditions, and further using gene editing technology to knockout PD-1 to finally obtain gene-edited TILs-T cells, and transfusing them back to the patient.

BIOLOGICAL

transfusion of maximum dose without side effects among group A, B and C

Obtaining individual tumor tissue via surgery resection or biopsy, and then isolating TILs in the tumor under GMP conditions, and further using gene editing technology to knockout PD-1 to finally obtain gene-edited TILs-T cells, and transfusing them back to the patient.

Trial Locations (1)

200025

RECRUITING

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

All Listed Sponsors
lead

Ruijin Hospital

OTHER