A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
NCT05451849 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2025-08-27
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
- BIOLOGICAL
-
TC-510
TC-510
- DRUG
-
Fludarabine
- DRUG
-
Cyclophosphamide
Sponsors & Collaborators
-
TCR2 Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-21
- Primary Completion
- 2028-10-30
- Completion
- 2028-10-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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