drugset / Trial / NCT05451849

A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer

NCT05451849 ↗

Phase 1/2 Terminated 14 enrolled TCR2 Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

TC-510 is a novel cell therapy that consists of autologous genetically engineered T cells expressing two synthetic constructs: first, a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex and second, a PD-1:CD28 switch receptor, which is expressed on the surface of the T cell, independently from the TCR. The PD-1:CD28 switch receptor comprises the PD-1 extracellular domain fused to the CD28 intracellular domain via a transmembrane domain. Thus, the switch is designed to produce a costimulatory signal upon engagement with PD-L1 on cancer cells.

Timeline

Start
2022-06-21
Primary completion
2025-08-30
Completion
2025-08-30

Outcome

Outcome not reported

Stopped (Enrollment): “No participants were enrolled in Phase 2 as Phase I was terminated early due to the lack of a clear signal of robust clinical activity.”

Drugs

EvaluationDrugModalityDoseRoute
Subject TC-510 Cell therapy — —
Background Cyclophosphamide Other / unclassified — —
Background Fludarabine Small molecule — —