TAC01-CLDN18.2 Engineered T-cells for Cancer
(TACTIC-3 Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, you must not have had chemotherapy, targeted small molecule therapy, or certain other treatments within specific timeframes before starting the trial. Please consult with the trial team for guidance on your specific medications.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, certain treatments like chemotherapy, targeted therapies, and immunosuppressive medications must be stopped a specific number of days before starting the trial. It's best to discuss your current medications with the trial team.
What data supports the idea that TAC01-CLDN18.2 Engineered T-cells for Cancer is an effective treatment?
The available research shows that TAC01-CLDN18.2 Engineered T-cells, which target the protein Claudin 18.2, have shown promising results in treating certain cancers. In a study involving solid tumors, 33% of patients experienced a reduction in tumor size, and 67% had their disease stabilized. Another study demonstrated that these T-cells, when modified with IL-15, significantly suppressed tumor growth in mice. Additionally, a trial targeting gastric cancer showed promising effectiveness and safety. These findings suggest that TAC01-CLDN18.2 could be a beneficial treatment option for cancers expressing Claudin 18.2.12345
What data supports the effectiveness of the treatment TAC01-CLDN18.2?
Research shows that T-cells engineered to target Claudin 18.2, a protein found in some cancer cells, have shown promising results in treating solid tumors. In studies, these engineered T-cells have demonstrated the ability to recognize and kill cancer cells expressing Claudin 18.2, suggesting potential effectiveness in treating cancers like gastric cancer.12345
What safety data exists for TAC01-CLDN18.2 T-cells for cancer treatment?
The safety data for TAC01-CLDN18.2, also known as CLDN18.2-targeted CAR T cells, indicates that these treatments have shown manageable toxicity profiles in clinical trials. In a phase 1 trial for gastrointestinal cancers, all patients experienced grade 3 or higher hematologic toxicity, and 94.6% had grade 1 or 2 cytokine release syndrome (CRS), but no grade 3 or higher CRS, neurotoxicities, treatment-related deaths, or dose-limiting toxicities were reported. Another study on CLDN6-specific CAR T cells reported manageable toxicity with cytokine release syndrome occurring in 46% of patients, including one grade 3 event. Overall, these treatments have shown promising efficacy with an acceptable safety profile in heavily pretreated patients with CLDN18.2-positive cancers.12367
What safety data exists for TAC01-CLDN18.2 Engineered T-cells for Cancer?
In a study of Claudin18.2-targeted CAR T cells for digestive system cancers, all patients experienced some blood-related side effects, but no severe cytokine release syndrome (a condition where the immune system overreacts) or neurotoxicities were reported. Another study on Claudin 6-targeted CAR T cells showed manageable safety with some patients experiencing cytokine release syndrome, but these effects were generally mild and resolved without long-term issues.12367
Is the treatment TAC01-CLDN18.2 a promising treatment for cancer?
How is the TAC01-CLDN18.2 treatment different from other cancer treatments?
TAC01-CLDN18.2 is unique because it uses engineered T-cells specifically targeting Claudin 18.2, a protein found in certain cancer cells, to enhance the immune system's ability to attack tumors. This approach is different from traditional treatments as it involves modifying the patient's own T-cells to recognize and destroy cancer cells, offering a personalized and potentially more effective therapy for cancers expressing Claudin 18.2.12389
Eligibility Criteria
This trial is for adults with certain advanced solid tumors that test positive for Claudin 18.2 and have undergone at least two prior therapies (one for pancreatic cancer). Participants must be in good health otherwise, not pregnant, willing to use contraception, and without a history of severe allergies or reactions to similar treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lymphodepletion followed by a single IV infusion of TAC01-CLDN18.2
Follow-up
Participants are monitored for safety, efficacy, and pharmacokinetics, including disease control rate and overall survival
Open-label extension (optional)
Participants may continue to receive TAC01-CLDN18.2 if they benefit from the treatment
Treatment Details
Interventions
- TAC01-CLDN18.2
Find a Clinic Near You
Who Is Running the Clinical Trial?
Triumvira Immunologics, Inc.
Lead Sponsor