Treatment of Advanced Solid Tumors With TSA-CTL(Tumor Specific Antigen-Induced Cytotoxic T Lymphocytes)

Solid Cancer Clinical Trial

Official title: Phase I Clinical Trial of TSA-CTL (Tumor Specific Antigen-Induced Cytotoxic T Lymphocytes) In the Treatment of Advanced Solid Tumors

Status Completed

Clinical Trial Summary

The primary objective of this study is to evaluate the safety of TSA-CTL in the treatment of advanced solid tumors.

The secondary objective of this study is to evaluate preliminarily the effect of TSA-CTL in the treatment of advanced solid tumors.

Clinical Trial Description

This is a single arm, open label and non-randomized clinical study with two parts.

In Part 1, 9 subjects with advanced solid tumors will be enrolled into Groups A (no non-myeloablative lymphodepletion), B and C (non-myeloablative lymphodepletion with different chemotherapy intensities) to assess the safety and dose intensity of non-myeloablative lymphodepletion chemotherapy before cell infusion.

Depending on results in Part 1, the study may proceed to Part 2, where 15 subjects with advanced solid tumors will be enrolled to receive TSA-CTL cell infusions with or without non-myeloablative lymphodepletion. ;

Related Conditions & MeSH terms

• Solid Cancer

• NCT number: NCT02959905
• Study type: Interventional
• Source: BGI, China
• Status: Completed
• Phase: Phase 1
• Start date: December 22, 2016
• Completion date: May 20, 2022