Table 1 Completed and ongoing clinical trials of GPRC5D-targeting agents.
From: GPRC5D as a novel target for the treatment of multiple myeloma: a narrative review
Trial name (ClinicalTrials.gov identifier) | Phase | Intervention | Patient population | Primary endpoint |
|---|---|---|---|---|
Talquetamab | ||||
MonumenTAL-1 (NCT03399799/ NCT04634552) | Phase 1/2 | Talquetamab monotherapy | Phase 1: Patients with RRMM who had progressed on or were intolerant to established therapies Phase 2: Patients with RRMM who had previously received ≥3 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 antibody | Phase 1: Safety and dose-limiting toxicities Phase 2: ORR |
MonumenTAL-2 (NCT05050097) | Phase 1b | Talquetamab + carfilzomib, daratumumab, lenalidomide, or pomalidomide | Patients with RRMM who have a ECOG performance status of 0/1 | Safety and dose-limiting toxicities |
TRIMM-2 (NCT04108195) | Phase 1b | Talquetamab or teclistamab + daratumumab ± pomalidomide | Patients with RRMM who have received ≥3 prior lines of therapy, including a PI, and an IMiD, or were double refractory to a PI and an IMiD, and had not received anti-CD38 therapy within 90 days | Safety and dose-limiting toxicities |
TRIMM-3 (NCT05338775) | Phase 1b | Talquetamab or teclistamab + a PD-1 inhibitor | Patients with RRMM who are not candidates for available therapy with established clinical benefit | Safety and dose-limiting toxicities |
RedirecTT-1 (NCT04586426) | Phase 1b/2 | Talquetamab + teclistamab ± daratumumab | Parts 1 & 2: Patients could not tolerate or have disease that is relapsed or refractory to established therapies, including the last line of therapy. Part 3: Relapsed or refractory disease, and exposed to a PI, an IMiD, and an anti-CD38 antibody; no prior BCMA-targeted bispecific antibody or prior GPRC5D targeted therapy allowed | Safety and dose-limiting toxicities |
Forimtamig | ||||
NCT04557150 | Phase 1 | Forimtamig monotherapy | Patients with RRMM who have previously received therapy with a PI and an IMiD and are intolerant to or have no other option for standard-of-care treatment per the investigator | Safety and dose-limiting toxicities |
MCARH109 | ||||
NCT04555551 | Phase 1 | MCARH109 | Patients with RRMM who have previously received ≥3 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 antibody therapy | Maximum tolerated dose |
NCT05431608 | Phase 1 | MCARH109 + MCARH125 | Patients with RRMM who have previously received ≥3 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 antibody therapy | Maximum tolerated dose |
OriCAR-017 | ||||
POLARIS (NCT05016778) | Phase 1 | OriCAR-017 | Patients who have received ≥3 lines of therapy, including chemotherapy, a PI, and an immunosuppressive agent, and have failed treatment or have progressed or recurred during the last treatment or within 6 months after the end of treatment | Safety and dose-limiting toxicities |
BMS-986393 | ||||
NCT04674813 | Phase 1 | BMS-986393 | Patients who have received ≥3 lines of therapy including a PI, an IMiD, and an anti-CD38 antibody therapy and, unless ineligible, prior stem cell transplant. Prior BCMA-directed and CAR-T therapies are allowed | Safety, dose-limiting toxicities, and maximum tolerated dose |
