A Phase I Clinical Study to Evaluate the Safety, the Tolerability, the Pharmacokinetic Characteristics and the Efficacy of ScTIL Injection (Genetically Modified Tumor Infiltrating Lymphocytes) in the Treatment of Advanced Malignant Solid Tumors

Phase 1 Unknown 48 enrolled Chinese Academy of Medical Sciences Beijing ChineoMedical Technology Co., Ltd · collab

NaSingle-groupOpen-labelTreatment

Summary

This is an open-lable, single-arm, dose escalation and dose extension phase I clinical study of ScTIL designed to observe and evaluate the safety, the tolerance, the pharmacokinetic characteristics and the effectiveness of ScTIL in the treatment of advanced malignant solid tumors, in order to provide the basis for the future clinical research to explore the best recommended phase II dose (PR2D) and treatment scheme.

Timeline

Start: 2022-09-30
Primary completion: 2024-05-30
Completion: 2024-08-30

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ScTIL	Cell therapy	5e+09 cells	Intravenous
Subject	ScTIL	Cell therapy	1e+10 cells	Intravenous
Subject	ScTIL	Cell therapy	2e+10 cells	Intravenous

Indications

No indication recorded.