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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 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.

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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.

Conditions Studied

Metastatic Solid Tumor

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

FieldValue
Enrollment Target 113 participants
Start Date 2023-08-23
Est. Completion 2027-08-01
Phase Phase 1

Sponsor

Triumvira Immunologics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05862324

The ClinicalTrials.gov registry entry for NCT05862324 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 190-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (41% lower). The listed sponsor is Triumvira Immunologics, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 9 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.