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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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 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.
University of California San Francisco
San Francisco, California, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
Number of participants with dose-limiting toxicities (DLTs)
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
Time frame: one year post infusion of IMA203
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
Used to evaluate safety and tolerability of treatment with IMA203 in combination with mRNA-4203
Time frame: one year post infusion of IMA203
Objective response rate (ORR)
complete response (CR) and partial response (PR) based on best overall response (BOR), locally assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: one year post infusion of IMA203
Duration of response (DOR)
CR and PR, locally assessed using RECIST v1.1
Time frame: one year post infusion of IMA203
Disease control rate (DCR)
CR, PR and stable disease (SD) lasting 6 or more weeks following the infusion of IMA203, locally assessed using RECIST v1.1
Time frame: one year post infusion of IMA203
Progression-free survival (PFS)
locally assessed using RECIST v1.1
Time frame: one year post infusion of IMA203
Concentration of IMA203 transgene in peripheral blood
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MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGEvaluate the pharmacokinetics of T-cell receptor (TCR) engineered T cells in combination with mRNA-4203
Time frame: one year post infusion of IMA203