Trial NCT06946225
ACTengine® IMA203 Combined With mRNA-4203
- Phase
- Phase 1
- Sponsor
- Immatics US, Inc.
- Conditions
- Cutaneous Melanoma; Synovial Sarcoma
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 0-1Performance status
* 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 yearsPrior malignancy
* Pregnant or breastfeedingPregnancy
* Serious autoimmune disease
* History of cardiac conditions as per protocolCardiac
* 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) infectionHIV
* Any condition contraindicating leukapheresis
* Participants with lactate dehydrogenase (LDH) greater than threshold allowed per protocol
* Participants with active brain metastases prior to lymphodepletionBrain metastases
* 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 protocolRenal
Other protocol defined exclusion criteria could apply
Restrictions found (7)
- Brain metastasesConditionalexclusionShow in the text
- CardiacConditionalexclusionShow in the text
- HIVOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0-1
Show in the text - PregnancyOutrightexclusionShow in the text
- Prior malignancyOutrightexclusion
within 3 years
Show in the text - RenalConditionalexclusionShow in the text
Recruiting in Massachusetts
- Dana Farber Cancer Institute · Boston, Suffolk County