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ACTengine® IMA203 Combined With mRNA-4203
Trial Status: active
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).
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
Additional locations may be listed on ClinicalTrials.gov for NCT06946225.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
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*02:01 positive patients with previously treated, unresectable or
metastatic cutaneous melanoma (CM) and synovial sarcoma (SS).
