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NCT03907852 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer
A Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by TCR2 Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 11
- Study locations
NCT03907852: Active Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by TCR2 Therapeutics.
NCT03907852 is a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer that is active but no longer recruiting, run by TCR2 Therapeutics. The registered enrollment target is 57 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (91% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03907852, a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, is active but no longer recruiting, sponsored by TCR2 Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 11
- Study locations
Study Summary
Gavocabtagene autoleucel (gavo-cel; TC-210) is a novel cell therapy that consists of autologous genetically engineered T cells expressing 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. This Phase 1/2 study aims to establish the recommended Phase 2 dose (RP2D) and subsequently evaluate the efficacy of gavo-cel, with and without immuno-oncology agents, in patients with advanced mesothelin-expressing cancers, with overall response rate and disease control rate as the primary Phase 2 endpoints.
Primary Outcome
Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG fludarabine
- DRUG cyclophosphamide
- BIOLOGICAL gavo-cel
Study Locations (11)
New York
- Columbia University Medical Center - New York
- Memorial Sloan Kettering Cancer Center - New York
California
- University of California, San Francisco - San Francisco
Florida
- University of Miami Sylvester Cancer Center - Miami
Illinois
- University of Chicago Medical Center - Chicago
Maryland
- National Cancer Institute - Bethesda
North Carolina
- Duke University - Durham
Pennsylvania
- University of Pennsylvania - Philadelphia
Tennessee
- SCRI Oncology Partners - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2019-04-15 |
| Est. Completion | 2028-11-02 |
| Phase | Phase 1 |
What the registry record for NCT03907852 still lists
NCT03907852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (91% lower).
The record links to 10 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Nivolumab is the first listed.
NCT03907852 lists 11 locations in 10 states (New York, California, Florida).
Frequently Asked Questions
What is clinical trial NCT03907852 about?
NCT03907852 is a clinical study titled "Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer". Gavocabtagene autoleucel (gavo-cel; TC-210) is a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell rec...
What is the current status of trial NCT03907852?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2019-04-15. Estimated completion is 2028-11-02.
What conditions does trial NCT03907852 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Ovarian Cancer, Cholangiocarcinoma, Mesothelioma, Non Small Cell Lung Cancer Metastatic.
What interventions are being tested in trial NCT03907852?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), fludarabine (DRUG), cyclophosphamide (DRUG), gavo-cel (BIOLOGICAL).
Who is sponsoring clinical trial NCT03907852?
This trial is sponsored by TCR2 Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03907852 being conducted?
This trial has 11 study locations across California, Florida, Illinois, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03907852's enrollment target sits among peer trials
57 322nd of 454 higher than 133 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
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