RecruitingPhase 1NCT06946225

ACTengine® IMA203 Combined With mRNA-4203

A First-in-human, Open-label Trial to Evaluate the Combination of ACTengine® IMA203 With mRNA-4203 in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma or Synovial Sarcoma Patients (ACTengine® IMA203-102)


Sponsor

Immatics US, Inc.

Enrollment

15 participants

Start Date

Jul 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This purpose of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA203 in combination with different doses of mRNA-4203. The trial includes participants with previously treated unresectable or metastatic cutaneous melanoma (CM) or synovial sarcoma (SS).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cutting-edge cancer treatments: ACTengine® IMA203, an engineered T-cell therapy that targets a protein called PRAME on cancer cells, plus an mRNA cancer vaccine (mRNA-4203), in people with advanced melanoma (skin cancer) or synovial sarcoma (a soft tissue cancer). **You may be eligible if...** - You have been diagnosed with unresectable or metastatic cutaneous melanoma or synovial sarcoma confirmed by biopsy - You have a specific genetic marker called HLA-A*02:01 (found through a blood test) - Your cancer has progressed despite at least one prior PD-1 immunotherapy (for melanoma) or you have received (or declined) standard chemotherapy (for synovial sarcoma) - You are in reasonably good physical condition (ECOG 0–1) with a life expectancy of more than 5 months - You have measurable disease on scans **You may NOT be eligible if...** - You do not have the HLA-A*02:01 genetic marker - You have active brain metastases that are untreated or unstable - Your organs are not functioning well enough for the treatment - You have active autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIMA203

Following non-myeloablative chemotherapy for lymphodepletion (LD) with fludarabine (FLU) and cyclophosphamide (CY), participants will receive a single infusion of IMA203 on Day 1 and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion.

BIOLOGICALmRNA-4203

mRNA-4203 will be administered starting on Day 15 after IMA203 infusion at the earliest. mRNA-4203 will be given for 12 cycles (28 day cycle length); during Cycle 1 it will be given on Day 1 and Day 15 and in Cycles 2-12 it will be given on Day 1.


Locations(4)

University of California San Francisco

San Francisco, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06946225


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