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CAR T-cell Therapy

TAC T-cells for Gastric Cancer (TACTIC-2 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Triumvira Immunologics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
For breast cancer patients, both prior lines of therapy must include HER2 targeted agents
Must not have
Acute cardiovascular disease
Active inflammatory or neurological disorder, autoimmune disease or infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2). The purpose of the trial is to establish the safety, maximum tolerated dose, and efficacy of the therapy in subjects with relapsed or refractory solid tumors.

Who is the study for?
Adults with HER2-positive stomach or gastroesophageal cancer that has returned or didn't respond after at least two treatments can join. They should be fairly active (ECOG 0-1), have organs working well, and a life expectancy over 12 weeks. Breast cancer patients must have had HER2-targeted therapy before.
What is being tested?
The trial is testing TAC01-HER2, a new type of cell therapy where patient's own immune cells are modified to attack cancer, alone and combined with pembrolizumab. It aims to find the safest dose, how it affects the body, and if it works against these cancers.
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as fever, fatigue, inflammation in various organs; also risks associated with pembrolizumab like skin rash or flu-like symptoms may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My previous breast cancer treatments included HER2-targeted therapies.
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I am 18 years old or older.
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My condition worsened or didn't improve after two treatments.
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My recent tumor sample shows HER2 protein on its surface.
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My previous breast cancer treatments included HER2-targeting drugs.
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My condition worsened or didn't improve after two treatments.
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I am fully active or can carry out light work.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a recent heart condition.
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I have an active inflammatory, neurological disorder, autoimmune disease, or infection.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Phase 1 and Phase 2: Cmax of TAC01-HER2 (pharmacokinetics; PK)
Phase 1 and Phase 2: Cytokine level detection
Phase 1 and Phase 2: Duration of persistence of TAC T cells (PK)
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: TAC01-HER2 plus pembrolizumabExperimental Treatment1 Intervention
Lymphodepletion followed by TAC01-HER2 as a single IV infusion, followed by pembrolizumab administration.
Group II: TAC01-HER2Experimental Treatment1 Intervention
Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,020 Previous Clinical Trials
5,186,835 Total Patients Enrolled
Triumvira Immunologics, Inc.Lead Sponsor
2 Previous Clinical Trials
113 Total Patients Enrolled

Media Library

TAC01-HER2 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04727151 — Phase 1 & 2
Gastric Cancer Research Study Groups: TAC01-HER2 plus pembrolizumab, TAC01-HER2
Gastric Cancer Clinical Trial 2023: TAC01-HER2 Highlights & Side Effects. Trial Name: NCT04727151 — Phase 1 & 2
TAC01-HER2 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04727151 — Phase 1 & 2
~7 spots leftby Dec 2025
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