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TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3)

NCT05862324 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2025-02-14

No results posted yet for this 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

  • Metastatic Solid Tumor

Interventions

BIOLOGICAL

TAC01-CLDN18.2

TAC01-CLDN18.2 preceded by lymphodepletion with fludarabine or clofarabine, cyclophosphamide, and nab-paclitaxel.

Sponsors & Collaborators

  • Triumvira Immunologics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-23
Primary Completion
2027-08-01
Completion
2027-08-01
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05862324 on ClinicalTrials.gov