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RECRUITING

NCT06946225

PHASE1

ACTengine® IMA203 Combined With mRNA-4203

Sponsor: Immatics US, Inc.

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-07-25

Completion Date

2029-08

Last Updated

2026-01-08

Healthy Volunteers

Conditions

Cutaneous Melanoma Synovial Sarcoma

Interventions

BIOLOGICAL

IMA203

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.

BIOLOGICAL

mRNA-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.

Inclusion Criteria: * Pathologically confirmed and documented cutaneous melanoma (CM) or synovial sarcoma (SS) with unresectable or metastatic disease * HLA-A\*02:01 positive * Adequate selected organ function per protocol * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) * Life expectancy more than 5 months * CM participants who must have disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor * SS participants must have received (or declined) at least one line of treatment (including SoC) and are still in need of further systemic therapy. * Female participants of childbearing potential must use adequate contraception prior to trial entry until 12 months after the infusion of IMA203 and 15 days after the last mRNA 4203 dose administration Other protocol defined inclusion criteria could apply Exclusion Criteria: * History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years * Pregnant or breastfeeding * Serious autoimmune disease * History of cardiac conditions as per protocol * Prior allogenic stem cell transplantation or solid organ transplantation * Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study * History of hypersensitivity to cyclophosphamide, fludarabine, or IL-2 * History of hypersensitivity to mRNA-based medicines * Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection * Any condition contraindicating leukapheresis * Participants with lactate dehydrogenase (LDH) greater than threshold allowed per protocol * Participants with active brain metastases prior to lymphodepletion * Concurrent treatment in another clinical trial or a device trial that could interfere with the IMA203 treatment * Participants with renal impairment AND reduced bone marrow reserve per protocol Other protocol defined exclusion criteria could apply

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