ACTengine® IMA203 Combined With mRNA-4203
Recruiting · NCT06946225 · Interventional (participants receive a specific treatment) · Lead sponsor: Immatics US, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
IMA203mRNA-4203
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
- ther 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
- ther protocol defined exclusion criteria could apply
Where it is running
4 locations listed across 4 US states.
- 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