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CAR T-cell Therapy

TAC01-CLDN18.2 Engineered T-cells for Cancer (TACTIC-3 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Triumvira Immunologics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

TACTIC-3 Trial Summary

This trial studies a new therapy that uses genetically engineered cells to target specific antigens in order to treat cancer. Its purpose is to test safety, dosage, and effectiveness.

Who is the study for?

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.Check my eligibility

What is being tested?

TAC01-CLDN18.2 cell therapy is being tested on patients with specific types of solid tumors. This therapy involves genetically modified T cells targeting the Claudin 18.2 protein on tumor cells. The study aims to find the safest dose and see how well it works.See study design

What are the potential side effects?

Potential side effects may include immune system reactions, infusion-related responses, fatigue, possible organ inflammation due to targeted T-cell activation, but exact side effects will be studied as part of this clinical trial.

TACTIC-3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Phase 2: Evaluate Disease control rate (DCR)

Phase 2: Evaluate Duration of Response (DoR)

+3 more

Secondary outcome measures

Phase 1: Determine MTD or RP2D for TAC01-CLDN 18.2

Phase 1: Evaluate Disease control rate (DCR)

Phase 1: Evaluate Duration of Response (DoR)

+4 more

Other outcome measures

Phase 1 and Phase 2: Cmax of TAC01-CLDN18.2 (pharmacokinetics; PK).

Phase 1 and Phase 2: Cytokine level detection

Phase 1 and Phase 2: Duration of persistence of TAC T cells (PK)

+4 more

TACTIC-3 Trial Design

1Treatment groups

Experimental Treatment

Group I: TAC01-CLDN18.2Experimental Treatment1 Intervention

Lymphodepletion followed by TAC01-CLDN18.2 as a single IV infusion.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Triumvira Immunologics, Inc.Lead Sponsor

2 Previous Clinical Trials

110 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open positions available for participants in this experiment?

"As referenced on clinicaltrials.gov, this investigation is still recruiting patients and was originally published on August 23rd 2023. The study information has been updated as recently as September 12th of the same year."

Answered by AI

What is the current enrollment limit for this research trial?

"Correct. Perusal of clinicaltrials.gov reveals that this medical study, initially posted on August 23rd 2023, is actively trying to recruit participants. Specifically, 113 individuals need to be sourced from 2 different trial centres."

Answered by AI

What is the objective of this medical research?

"According to the trial sponsor, Triumvira Immunologics, Inc., this study has a primary endpoint of evaluating overall response rate (ORR) over two years. Secondary outcomes will include assessing ORR using RECIST Version 1.1 imaging criteria; measuring duration of response from first response to progression endpoints; and recording overall survival from infusion to death as well as TAC cell persistence time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05862324.