A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
A Phase 1/2 Single Arm Open-Label Clinical Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
1 other identifier
interventional
6
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2022
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2022
CompletedStudy Start
First participant enrolled
June 21, 2022
CompletedFirst Posted
Study publicly available on registry
July 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2028
August 27, 2025
August 1, 2025
6.4 years
June 21, 2022
August 20, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (1)
Lymphodepletion followed by TC-510
EXPERIMENTALLymphodepletion (fludarabine and cyclophosphamide) followed by TC-510 T cells
Interventions
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- Inability to follow the procedures of the study
- Known or suspected non-compliance, drug, or alcohol use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of California, San Francisco
San Francisco, California, 94143, United States
University of Miami
Miami, Florida, 33146, United States
National Cancer Institute
Bethesda, Maryland, 20814, United States
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Montefiore Einstein Cancer Center
The Bronx, New York, 10461, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2022
First Posted
July 11, 2022
Study Start
June 21, 2022
Primary Completion (Estimated)
October 30, 2028
Study Completion (Estimated)
October 30, 2028
Last Updated
August 27, 2025
Record last verified: 2025-08