TAC T-Cells for Treating Claudin 18.2 Positive Solid Tumors (TACTIC-3)

Sponsor: Triumvira Immunologics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05862324

Provider View

This study is testing a new cell therapy called TAC01-CLDN18.2, which uses modified T-cells to target and attack solid tumors that express a protein called Claudin 18.2. The trial aims to determine the safety and effectiveness of this treatment in patients with advanced cancers.

Patient Parameters

Program Overview

The study is exploring a new treatment using TAC T-cells, which are a type of genetically modified T-cell designed to recognize and attack cancer cells with a specific protein, Claudin 18.2. This protein is found on the surface of certain tumor cells. The trial is open to adults with advanced solid tumors that have this protein and have already undergone at least two previous treatments. The study will test different doses to find the safest and most effective one, and will evaluate how well the treatment works in shrinking tumors.

Description

This clinical trial is investigating a new approach to cancer treatment using TAC T-cells, which are specially engineered to target a protein called Claudin 18.2 found on some cancer cells. These modified T-cells are made from a patient's own cells and are designed to seek out and destroy cancer cells expressing this protein.

The study is divided into two phases. In Phase 1, researchers will test different doses of the TAC T-cells to find the safest and most effective dose. In Phase 2, they will further evaluate the treatment's effectiveness in patients with specific types of cancer, including gastric, esophageal, pancreatic, ovarian, and non-small cell lung cancers.

Participants must have advanced cancer that cannot be removed by surgery and has not responded to at least two previous treatments. The study will monitor the safety of the treatment and its ability to shrink tumors. Participants will undergo various tests and procedures to ensure they meet the study criteria and to track their response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a tumor that tests positive for Claudin 18.2.
  • Have advanced cancer that cannot be surgically removed and has been treated with at least two prior therapies.
  • Have specific types of cancer, such as gastric, esophageal, pancreatic, ovarian, or non-small cell lung cancer.
  • Have measurable disease according to standard criteria.
  • Be in good overall health with a performance status of 0 or 1.
  • Have a life expectancy of at least 12 weeks.
  • Have adequate organ and bone marrow function.
  • Women capable of becoming pregnant must agree to use effective contraception during and for one year after treatment.
  • Men must agree to use effective contraception and not donate sperm during and for one year after treatment.
  • Have controlled hepatitis B or C infections, if applicable.

Exclusion Criteria

  • Cannot tolerate any component of the TAC01-CLDN18.2 treatment.
  • Have had previous treatments with certain types of cell or gene therapies.
  • Have received a live vaccine within 30 days before starting the study treatment.
  • Have active or untreated brain metastases.
  • Have certain neurological or autoimmune disorders.
  • Have uncontrolled infections or significant heart disease.
  • Have had another cancer that is progressing or requires treatment.
  • Are pregnant or breastfeeding.
  • Have any condition that would prevent compliance with the study protocol.

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