Status:
RECRUITING
ACTengine® IMA203 Combined With mRNA-4203
Lead Sponsor:
Immatics US, Inc.
Collaborating Sponsors:
ModernaTX, Inc.
Conditions:
Cutaneous Melanoma
Synovial Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 pre...
Detailed Description
This clinical trial is a multi-center, open-label, non-comparative Phase 1 a/b trial to assess the safety, tolerability, and anti-tumor activity of the combination of IMA203 and mRNA-4203 in HLA-A\*02...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06946225
Start Date
July 25 2025
End Date
August 1 2029
Last Update
January 8 2026
Active Locations (4)
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1
University of California San Francisco
San Francisco, California, United States, 94143
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030