A Safety And Efficacy Study Of Allogeneic CAR Gamma-Delta T Cells in Subjects With Relapsed/Refractory Solid Tumors — CAR001  

Solid Tumor Clinical Trial

Official title: A Single Arm, Open Label, Dose-escalation Phase I and Dose-expansion Phase IIa Clinical Study to Evaluate the Feasibility, Safety, and Efficacy of Allogeneic Chimeric Antigen Receptor (CAR) Gamma-Delta T Cells CAR001 in Subjects With Relapsed/Refractory Solid Tumors

Status Not yet recruiting

Clinical Trial Summary

This study is composed of phase I and IIa parts. The dose-escalation phase I part aims to find the maximum tolerated dose (MTD) and to identify the safety of CAR001 in subjects with relapsed/refractory solid tumor; the dose-expansion phase IIa part aims to evaluate the potential efficacy of CAR001 in subjects with relapsed/refractory non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC) or Glioblastoma multiforme (GBM).

Clinical Trial Description

Primary Objective:

Phase I:

To evaluate the safety of CAR001 in subjects.

Phase IIa:

To provide potential evidence for the clinical efficacy of CAR001 in improving tumor response rate in subjects.

Secondary Objectives:

To evaluate the safety and potential efficacy of CAR001 in subjects.

Exploratory:

Level of CAR-positive γδT cells in peripheral blood from baseline to subsequent visits. (Time Frame: 12 months after the last infusion) ;

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

• NCT number: NCT06150885
• Study type: Interventional
• Source: Ever Supreme Bio Technology Co., Ltd.
• Contact: Sammi Hsu
• Phone: +886422052121
• Email: cthsu@ever-supreme.com.tw
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 30, 2024
• Completion date: September 30, 2027