mRNA-4203 / Moderna - LARVOL DELTA

A first-in-human, phase 1 trial of IMA203 PRAME-directed TCR T-cell therapy with PRAME-encoding mRNA-4203 in previously treated, unresectable or metastatic cutaneous melanoma or synovial sarcoma (SITC 2025) - P1, P1/2 | "Patients undergo lymphodepletion with cyclophosphamide (500 mg/m2 and fludarabine 30 mg/m2 x 4 days), followed by a one-time infusion of IMA203 and low-dose IL-2 given subcutaneously x10 days. and Moderna Inc.Trial Registration NCT06946225Ethics Approval The protocol and all amendments were approved by the appropriate institutional review board or independent ethics committee at each participating study site. The study is being conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines."

First-in-human • IO biomarker • Metastases • P1 data • Cutaneous Melanoma • Melanoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • HLA-A • PRAME

ACTengine® IMA203 Combined With mRNA-4203 (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Immatics US, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cutaneous Melanoma • Melanoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma

ACTengine® IMA203 Combined With mRNA-4203 (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Immatics US, Inc. | Initiation date: May 2025 ➔ Aug 2025

Trial initiation date • Cutaneous Melanoma • Melanoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma