MAGE-A4/MAGE-A8-targeted TCR-based bispecific T cell engager in recurrent and/or refractory solid tumors: a phase 1 trial - PubMed
4 hours ago
- #solid tumors
- #TCR-based therapy
- #phase 1 trial
- IMA401 is a TCR-based bispecific T cell engager (TCER) targeting MAGE-A4/MAGE-A8 peptides presented on HLA-A*02:01, designed with a high-affinity TCR domain, low-affinity T-cell-recruiting domain, and an optimized Fc for prolonged half-life.
- In a phase 1 trial of 61 patients with advanced solid tumors, the maximum tolerated dose (MTD) was not reached; the recommended phase 2 dose (RP2D) was 1-2 mg IMA401 biweekly, with manageable safety including cytokine release syndrome (38%), lymphopenia (33%), and neutropenia (31%), and one possibly-related death reported outside RP2D.
- Antitumor activity showed an overall confirmed objective response rate (ORR) of 14% (8/56) across all doses, increasing to 20% (8/41) at RP2D across 15 indications, with a notable ORR of 29% (4/14) in head and neck cancer patients and a median response duration of 8.8 months, indicating promising efficacy.