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

Study Overview

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

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.

N/A

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

BIOLOGICAL: TC-510
DRUG: Fludarabine
DRUG: Cyclophosphamide

TCR2-21-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-06-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-20
First Submitted that Met QC Criteria 2022-07-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-27
First Posted (ACTUAL) 2022-07-11	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Lymphodepletion followed by TC-510 Lymphodepletion (fludarabine and cyclophosphamide) followed by TC-510 T cells	BIOLOGICAL: TC-510 TC-510 DRUG: Fludarabine Fludarabine DRUG: Cyclophosphamide Cyclophosphamide

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Lymphodepletion followed by TC-510

Lymphodepletion (fludarabine and cyclophosphamide) followed by TC-510 T cells

BIOLOGICAL: TC-510

TC-510

DRUG: Fludarabine

Fludarabine

DRUG: Cyclophosphamide

Cyclophosphamide

Primary Outcome Measures	Measure Description	Time Frame
Phase 1 - Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.	Phase 1 -The number and percent of patients in the DLT evaluable set who experienced DLTs from the first administration of study drug up to 28 days post study drug treatment will be summarized by dosing group	DLTs within 28 days post-treatment
Phase 2 - Overall Response Rate (ORR)	ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1	Up to 2 years post-treatment
Phase 2 - Disease Control Rate (DCR)	DCR defined as a composite of ORR and stable disease (SD) lasting at least 8 weeks.	Up to 2 years post-treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patient is > 18 years of age at the time the Informed Consent is signed.
Patient has a pathologically confirmed diagnosis of either MPM, Serous Ovarian Adenocarcinoma, Pancreatic Adenocarcinoma, TNBC, and Colorectal Cancer
Patient's tumor has been reviewed with confirmed positive MSLN expression on >/= 50% of tumor cells that are 1+, 2+ and/or 3+ by immunohistochemistry. Patients with epithelioid MPM, confirmation of MSLN expression is not required prior to enrollment.
Prior to TC-510 infusion, patients must have received at least 1 but no more than 5 systemic therapies for metastatic or unresectable disease with more details provided in the protocol
Patients has an ECOG performance status 0 or 1
Patient is fit for leukapheresis and has adequate venous access for the cell collection.
Patient must have adequate organ function as indicated by the laboratory values in the clinical protocol

Inability to follow the procedures of the study
Known or suspected non-compliance, drug, or alcohol use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record