NCT05451849

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

A Phase 1/2 Single Arm Open-Label Clinical Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: TCR2 Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mesothelioma
• Mesotheliomas Pleural
• Mesothelioma, Malignant
• Mesothelioma Peritoneum
• Ovarian Cancer
• Ovarian Serous Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Adenocarcinoma
• Colorectal Cancer
• Triple Negative Breast Cancer
• TNBC - Triple-Negative Breast Cancer
• Ovarian Adenocarcinoma
• Pancreatic Neoplasms
• Colorectal Neoplasms
• Ovarian Neoplasms
• Cholangiocarcinoma
• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	TC-510	TC-510
DRUG	Fludarabine	Fludarabine
DRUG	Cyclophosphamide	Cyclophosphamide

Timeline

• Start date: 2022-06-21
• Primary completion: 2028-10-30
• Completion: 2028-10-30
• First posted: 2022-07-11
• Last updated: 2025-08-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study