← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

TACTIC-2 Trial 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.Check my eligibility

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.See study design

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.

TACTIC-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My previous breast cancer treatments included HER2-targeted therapies.

Select...

I am 18 years old or older.

Select...

My condition worsened or didn't improve after two treatments.

Select...

My recent tumor sample shows HER2 protein on its surface.

Select...

My previous breast cancer treatments included HER2-targeting drugs.

Select...

My condition worsened or didn't improve after two treatments.

Select...

I am fully active or can carry out light work.

Select...

I am fully active or can carry out light work.

TACTIC-2 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 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

TACTIC-2 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.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,443 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

Frequently Asked Questions

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

How many healthcare facilities are currently administering this research trial?

"This trial is currently recruiting from Princess Margaret Cancer Centre in Toronto, University of Chicago in Illinois and Rutgers Cancer Institute of New jersey as well as 5 additional sites."

Answered by AI

How many participants have been admitted to this research project?

"Correct. Clinicaltrials.gov confirms that recruitment for this medical trial is ongoing, as the study was originally posted on April 19th 2021 and has been modified most recently on April 27th 2022. A total of 70 patients are needed from 5 different sites."

Answered by AI

Is recruitment still taking place for this experiment?

"Affirmative. According to the clinicaltrials.gov portal, this medical experiment is currently open for recruitment and was initially posted on April 19th 2021. Currently, 70 participants need to be enrolled from 5 different healthcare locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TAC T-cells for the Treatment of HER2-positive Solid Tumors

2021. "TAC T-cells for the Treatment of HER2-positive Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04727151.

All > Gastric Cancer