ACTengine® IMA203 Combined With mRNA-4203
Recruiting now · Phase 1
Conditions studied: Cutaneous Melanoma, Synovial Sarcoma
In brief
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).
Key facts
- Study ID
- NCT06946225
- Run by
- Immatics US, Inc.
- People needed
- 15
- Starts
- 2025-07-25
- Expected to finish
- 2029-08-01
- Last updated by the study team
- 2026-01-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of California San Francisco — San Francisco, California, United States (enrolling)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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