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NCT05862324 · ClinicalTrials.gov registry record · Phase 1
TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3)
A Phase 1 study of Metastatic Solid Tumor, sponsored by Triumvira Immunologics.
- Active
- Registry status
- Phase 1
- Development phase
- 113
- Enrollment target
- 9
- Study locations
NCT05862324: Active Phase 1 study of Metastatic Solid Tumor, sponsored by Triumvira Immunologics.
NCT05862324 is a Phase 1 study of Metastatic Solid Tumor that is active but no longer recruiting, run by Triumvira Immunologics. The registered enrollment target is 113 participants, below the 190-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (41% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05862324, a Phase 1 study of Metastatic Solid Tumor, is active but no longer recruiting, sponsored by Triumvira Immunologics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 113 participants
- Enrollment target
- 9
- Study locations
Study Summary
TAC01-CLDN18.2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes Claudin 18.2. TAC directs T-cells to the targeted antigen (CLDN 18.2), and once engaged with the target, activates them via the endogenous T cell receptor. This is an open-label, multicenter Phase ½ study that aims to establish safety, maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), pharmacokinetic profile and efficacy of TAC01-CLDN18.2.
Primary Outcome
Document incidence of DLTs; Type, frequency, and severity of AEs (including clinically significant laboratory abnormalities).
Conditions Studied
Interventions
- BIOLOGICAL TAC01-CLDN18.2
Study Locations (9)
California
- University of Southern California - Los Angeles
- University of California San Diego - San Diego
Florida
- University of Miami Sylvester Comprehensive Cancer Center - Miami
Massachusetts
- Dana Farber Cancer Institute - Boston
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Cincinnati Cancer Center - Cincinnati
Texas
- MD Anderson Cancer Center - Houston
Ontario
- Princess Margaret Cancer Center - Toronto
Quebec
- Centre hospitalier de l'Université de Montréal - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2023-08-23 |
| Est. Completion | 2027-08-01 |
| Phase | Phase 1 |
What the registry record for NCT05862324 still lists
NCT05862324 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 190-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Metastatic Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which TAC01-CLDN18.2 is the first listed.
NCT05862324 lists 9 locations in 8 states (California, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05862324 about?
NCT05862324 is a clinical study titled "TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3)". TAC01-CLDN18.2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes Claudin 18.2. TAC directs T-cells to the targeted antigen (CLDN 18.2), and once engaged with the target, activates them via the endogenous T cell ...
What is the current status of trial NCT05862324?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 113 participants. The study started on 2023-08-23. Estimated completion is 2027-08-01.
What conditions does trial NCT05862324 study?
This clinical trial studies the following conditions: Metastatic Solid Tumor.
What interventions are being tested in trial NCT05862324?
The interventions under investigation include: TAC01-CLDN18.2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05862324?
This trial is sponsored by Triumvira Immunologics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05862324 being conducted?
This trial has 9 study locations across California, Florida, Massachusetts, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05862324's enrollment target sits among peer trials
113 29th of 52 higher than 24 of 52 other Metastatic Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Solid Tumor 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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