ACTengine® IMA203 Combined With mRNA-4203
Condition(s) studied
Investigational drug(s) / intervention(s)
IMA203: Following non-myeloablative chemotherapy for lymphodepletion (LD) with fludarabine (FLU) and cyclophosphamide (CY), participants will receive a single infusion of IMA203 on Day 1 and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion.
mRNA-4203: mRNA-4203 will be administered starting on Day 15 after IMA203 infusion at the earliest. mRNA-4203 will be given for 12 cycles (28 day cycle length); during Cycle 1 it will be given on Day 1 and Day 15 and in Cycles 2-12 it will be given on Day 1.
Study 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 previously treated unresectable or metastatic cutaneous melanoma (CM) or synovial sarcoma (SS).
Eligibility
Primary outcome measure(s)
- Number of participants with dose-limiting toxicities (DLTs) — one year post infusion of IMA203
Number of DLTs will be used to determine the maximum tolerated dose (MTD) and/or recommended dose for extension (RDE) after treatment with IMA203 product in combination with mRNA-4203 - Number of treatment emergent adverse events (AEs), AEs of special interest, serious AEs (SAEs), changes in laboratory parameters and vital signs, and frequency of dose interruptions, reductions and discontinuations — one year post infusion of IMA203
Used to evaluate safety and tolerability of treatment with IMA203 in combination with mRNA-4203
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California San Francisco | San Francisco | California | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
More Immatics US, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06946225 on ClinicalTrials.gov ↗ ← All trials in the USA