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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-21

Study Completion Date

2028-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lymphodepletion followed by TC-510

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

Group Type EXPERIMENTAL

TC-510

Intervention Type BIOLOGICAL

TC-510

Fludarabine

Intervention Type DRUG

Fludarabine

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide

Interventions

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TC-510

Intervention Type BIOLOGICAL

Fludarabine

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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