TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3) (NCT05862324) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3)
United States, Canada113 participantsStarted 2023-08-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed, written informed consent obtained before any study procedures are conducted.
. Age ≥ 18 years at the time of informed consent.
. Tumor tissue samples positive for CLDN18.2 as assessed by central laboratory.
. Histologically confirmed advanced, metastatic, unresectable CLDN18.2+ solid tumors after at least 2 lines of prior therapy (Phase 1) and after at least 2 and no more than 4 prior lines of therapy (Phase 2). Subjects with PDAC may have been treated with 1 line of prior therapy.
. Subjects with incurable Claudin 18.2 expressing malignancies for which no standard-of-care targeted therapy exists may be enrolled regardless of the number of prior treatment lines.
. Specific Phase 1 tumor types include gastric, GEJ, esophageal adenocarcinoma, PDAC, colorectal cancer, cholangiocarcinoma, ovarian mucinous cancer, gallbladder cancer and NSCLC.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is currently active but no longer enrolling new patients — does that mean there's any possibility of joining a waitlist, or should we focus entirely on finding other options?
2Since this is a Phase 1/Phase 2 trial using TAC T-cells targeting Claudin 18.2, can you tell me whether my tumor has been tested for Claudin 18.2 expression, and how that affects whether this approach could even be relevant for me?
3The Phase 1 part of this trial is primarily measuring safety and side effects of this T-cell therapy — what kinds of immune-related or serious adverse events have been reported so far, and how do they compare to what I might experience with standard treatment?
4TAC T-cell therapy is a relatively new type of cell-based immunotherapy — how does it differ mechanically from other treatments I might be considering, and what would recovery or monitoring look like if I were ever in a similar trial?
5Given that Phase 2 is measuring things like overall survival and progression-free survival, but those results aren't yet available, how should I weigh this experimental approach against currently approved treatments for my specific tumor type?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Timeframe: 24 Months
2
Phase 2: Evaluate Overall Response Rate (ORR)
Timeframe: 24 Months
3
Phase 2: Evaluate Duration of Response (DoR)
Timeframe: 24 Months
4
Phase 2: Evaluate Overall survival (OS)
Timeframe: 24 Months
5
Phase 2: Evaluate Disease control rate (DCR)
Timeframe: 24 Months
6
Phase 2: Evaluate Progression-Free survival (PFS) or Time to progression (TTP)
. Specific Phase 2 tumor types include gastric and esophageal adenocarcinoma (Group A), PDAC (Group B), and ovarian or NSCLC (Group C). Other tumor types are not eligible.
. Subjects with solid tumors with genetic alterations and mutations (e.g., BRAF, BRCA, EGFR mutations, and ALK translocation) where approved targeted therapies were available to their specific cancers must have been previously treated with such approved therapies, or refused such approved targeted therapy for their cancers, prior to enrollment, or in the opinion of the Investigator would be unlikely to tolerate or derive clinically meaningful benefit from these standard-of-care therapies.
Exclusion criteria
. Intolerant to any component of TAC01-CLDN18.2
. Prior treatment with any of the following:
. Adoptive cell transfer of any kind, including CAR T cells.
. Gene therapy
. Prior treatment with a CLDN18.2 targeted agent (Phase 2 only)
. Investigational medicinal product within 5 half-lives or 21 days prior to leukapheresis, whichever is shorter.
. Participation in or has participated in a study using an investigational device within 4 weeks prior to the first dose of study treatment.
. Receipt of a live or live-attenuated vaccine within 30 days prior to the first dose of study Intervention. Administration of killed vaccines are allowed.