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NCT05451849 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
A Phase 1 study of Colorectal Cancer and Ovarian Cancer, sponsored by TCR2 Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 7
- Study locations
NCT05451849: Active Phase 1 study of Colorectal Cancer and Ovarian Cancer, sponsored by TCR2 Therapeutics.
NCT05451849 is a Phase 1 study of Colorectal Cancer and Ovarian Cancer that is active but no longer recruiting, run by TCR2 Therapeutics. The registered enrollment target is 6 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (100% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05451849, a Phase 1 study of Colorectal Cancer and Ovarian Cancer, is active but no longer recruiting, sponsored by TCR2 Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
TEAEs are defined as AEs that were reported or worsened on or after the first administration of protocol-defined lymphodepleting chemotherapy through 3 months after the last infusion of TC-510. To be defined as serious, the event met at least one of the following serious criteria: * Fatal * Life-threatening (places the patient at immediate risk of death) * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacit
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 |
What the registry record for NCT05451849 still lists
NCT05451849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (100% lower).
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.
NCT05451849 lists 7 locations in 7 states (California, Florida, Maryland).
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.
What interventions are being tested in trial NCT05451849?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), TC-510 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05451849?
This trial is sponsored by TCR2 Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05451849's enrollment target sits among peer trials
6 375th of 381 higher than 7 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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