drugset / Trial / NCT05730361

Phase Ib Clinical Study on the Safety, the Tolerability, the Pharmacokinetics and the Efficacy of ScTIL Injection (Gene Modified Tumor Infiltrating Lymphocytes) Alone and in Combination With B Lymphocyte Adjuvant in the Treatment of Digestive System Malignant Solid Tumors

NCT05730361

Phase 1 Unknown 48 enrolled Peking University
NaSingle-groupOpen-labelTreatment

Summary

This is an open-lable, single-arm, single-dose escalation and multiple-dose extention clinical study of cell therapy designed to observe and evaluate the tolerance, the pharmacokinetic characteristics, the safety and the efficacy of ScTIL210 injection alone and in combination with B lymphocytes adjuvant in the treatment of digestive system malignant solid tumors.

Timeline

Start
2023-02
Primary completion
2024-05
Completion
2024-08

Drugs

EvaluationDrugModalityDoseRoute
Subject B lymphocytes adjuvant Unknown 5e+09 cells
Subject B lymphocytes adjuvant Unknown 1.5e+10 cells
Subject ScTIL Cell therapy 5e+09 cells Intravenous
Subject ScTIL Cell therapy 1.5e+10 cells Intravenous