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A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
NCT05451849 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL TC-510
Study Locations (7)
California
- University of California, San Francisco — San Francisco
Florida
- University of Miami — Miami
Maryland
- National Cancer Institute — Bethesda
Minnesota
- University of Minnesota, Masonic Cancer Center — Minneapolis
New York
- Montefiore Einstein Cancer Center — The Bronx
Oklahoma
- University of Oklahoma — Oklahoma City
Tennessee
- SCRI Oncology Partners — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2022-06-21 |
| Est. Completion | 2028-10-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05451849
The ClinicalTrials.gov registry entry for NCT05451849 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TCR2 Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05451849 reports 7 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05451849 about?
NCT05451849 is a clinical study titled "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 recepto...
What is the current status of trial NCT05451849?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2022-06-21. Estimated completion is 2028-10-30.
What conditions does trial NCT05451849 study?
This clinical trial studies the following conditions: Colorectal Cancer, Ovarian Cancer, Pancreatic Cancer, Triple Negative Breast Cancer, Pancreatic Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05451849?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), TC-510 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05451849?
This trial is sponsored by TCR2 Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05451849 being conducted?
This trial has 7 study locations across California, Florida, Maryland, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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