Investigational Drug
IMA203
TrialFetch AI Analysis
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Overview
IMA203 is an investigational, patient-specific T-cell therapy being studied for advanced solid tumors, including melanoma. It has produced responses in early clinical trials, but its benefit has not yet been established in a randomized trial. A phase 3 trial in previously treated advanced cutaneous melanoma has been described. (nature.com)
Mechanism of action
A patient’s T cells are modified to carry a T-cell receptor that recognizes a peptide from PRAME (preferentially expressed antigen in melanoma) when presented by HLA-A*02 on tumor cells. Trial eligibility therefore depends on both tumor PRAME expression and the patient’s HLA type. (nature.com)
Efficacy
In a published phase 1 analysis across several tumor types, 11 of 38 evaluable patients (28.9%) had a confirmed objective response. Counting both confirmed and unconfirmed responses, the rate was 21 of 40 (52.5%); median response duration was 4.4 months. These are interim, single-arm results and should not be interpreted as a comparison with standard treatment. (nature.com)
A later conference abstract focused on uveal melanoma reported confirmed responses in 10 of 15 evaluable patients (67%), with a median response duration of 11.0 months. That subgroup was small, and the finding remains preliminary. (annalsofoncology.org)
Safety
In the published phase 1 analysis, severe cytokine release syndrome occurred in 2 of 41 patients (4.9%) who began treatment; no severe neurotoxicity was reported. Cytokine release syndrome of any grade was common (92.7%), while 12.2% had mild or moderate neurotoxicity. Severe low blood-cell counts were also common following the chemotherapy used to prepare patients for infusion. (nature.com)
Further reading
- Peer-reviewed phase 1 report, Nature Medicine
- Uveal melanoma phase 1 conference abstract, Annals of Oncology
- Phase 3 trial-design abstract, Journal of Clinical Oncology
Last updated: Sep 2026
Active trials using IMA203
Found 3 active trials using this drug:
TrialFetch AI summary: This trial enrolls HLA-A*02:01-positive patients with previously treated, unresectable or metastatic cutaneous melanoma or synovial sarcoma; melanoma must have progressed on or after PD-1 inhibition. Patients receive autologous IMA203 T cells engineered to recognize HLA-A*02–presented PRAME, combined with dose-escalated mRNA-4203, which is designed to increase PRAME presentation and stimulate the engineered T cells.
ClinicalTrials.gov ID: NCT06946225
TrialFetch AI summary: This trial enrolls HLA-A*02:01-positive patients with unresectable or metastatic cutaneous melanoma, including acral melanoma, whose disease progressed on or after PD-1 therapy; patients with BRAF-mutant disease generally must also have received BRAF-directed therapy. It compares autologous IMA203, a T-cell receptor therapy targeting a PRAME peptide presented by HLA-A*02, after lymphodepletion and followed by low-dose IL-2, with investigator-selected immunotherapy, lifileucel, or chemotherapy.
ClinicalTrials.gov ID: NCT06743126
TrialFetch AI summary: Patients with recurrent or refractory solid tumors after standard treatment may be eligible if they are HLA-A*02:01-positive, have PRAME-expressing tumors and measurable disease, and have ECOG performance status 0–1. After lymphodepletion, they receive autologous T cells engineered with a receptor targeting PRAME presented by HLA-A*02:01 (IMA203 or CD8-enhanced IMA203CD8); some cohorts also receive IL-2 or, with IMA203, the PD-1 inhibitor nivolumab.
ClinicalTrials.gov ID: NCT03686124
