This study is in progress, not accepting new patients

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

a study on Mesothelioma Ovarian Cancer Ovarian Serous Adenocarcinoma Pancreatic Cancer Colorectal Cancer Breast Cancer Triple-Negative Breast Cancer Pancreatic Neoplasms Colorectal Tumor Cholangiocarcinoma Lung Cancer Non-Small Cell Lung Cancer Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

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, Breast Neoplasms, Neoplasms, Adenocarcinoma, Triple Negative Breast Neoplasms, Malignant Mesothelioma, Serous Cystadenocarcinoma, Cyclophosphamide, Fludarabine, Lymphodepletion followed by TC-510

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

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

Locations

  • University of California, San Francisco
    San Francisco California 94143 United States
  • University of Oklahoma
    Oklahoma City Oklahoma 73104 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TCR2 Therapeutics
ID
NCT05451849
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 6 people participating
Last Updated