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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05451849
• Other study ID #: TCR2-21-01
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: June 21, 2022
• Est. completion date: October 30, 2028

Study information

• Verified date: March 2024
• Source: TCR2 Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: October 30, 2028
• Est. primary completion date: October 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Inability to follow the procedures of the study

• Known or suspected non-compliance, drug, or alcohol use

Related Conditions & MeSH terms

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

Intervention

Biological:
• TC-510
TC-510

Drug:
• Fludarabine
Fludarabine
• Cyclophosphamide
Cyclophosphamide

Locations

Country	Name	City	State
United States	National Cancer Institute	Bethesda	Maryland
United States	Montefiore Einstein Cancer Center	Bronx	New York
United States	University of Miami	Miami	Florida
United States	University of Minnesota, Masonic Cancer Center	Minneapolis	Minnesota
United States	SCRI Oncology Partners	Nashville	Tennessee
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
TCR2 Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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