Table 1.
Overview of clinical trials investigating bispecific antibodies (bsAbs) in multiple myeloma.
| ClinicalTrials.gov Identifier | Bispecific Antibody | Targets | Study Phase | Estimated Enrollment | Current Status * | Response Rates | AEs ≥ Grade 3 |
|---|---|---|---|---|---|---|---|
| NCT02514239 | AMG420 | BCMA/CD3 | 1 | 43 patients | Active, not recruiting | 42 patients were treated. ORR: 31% (13/42); at MTD of 400 µg/d: 70% (7/10) including 50% (5/10) MRD-negative CR | 19% (n = 8) infection, 5% (n = 2) peripheral polyneuropathy, 2% (n = 1) edema, and 2% (n = 1) CRS |
| NCT03836053 | AMG420 | BCMA/CD3 | 1/2 | 15 patients | Recruiting | N/A | N/A |
| NCT03269136 | PF-3135 | BCMA/CD3 | 1 | 80 patients | Recruiting | 17 patients were treated. Response data were available in 16 patients. CBR: 41%; 6% (1/16) MR, 35% (6/16) SD, and 53% (9/16) PD | 18% (n = 3) including elevated transaminase, leukocytopenia, neutropenia, and lymphopenia |
| NCT03145181 | JNJ-64007957 | BCMA/CD3 | 1 | 160 patients | Recruiting | Activity was observed in 52 patients who received ≥ 38.4 µg/kg. ORR: 38% (20/52); at 270 µg/kg: 78% (7/9) | 21% (n = 14) infection, 20% (n = 13) neutropenia, 14% (n = 9) anemia, 3% (n = 2) neurotoxicity, 2% (n = 1) delirium, and 2% (n = 1) thrombocytopenia. One patient died due to pneumonia (grade 5) |
| NCT03933735 | TNB-383B | BCMA/CD3 | 1 | 72 patients | Recruiting | N/A | N/A |
| NCT03486067 | CC-93269 | BCMA/CD3 | 1 | 120 patients | Active, not recruiting | 12 patients were treated with ≥ 6 mg CC-93269. ORR: 83% (10/12) with 58% (7/12) ≥ VGPR and 33% (4/12) sCR; MRD-negative CR rate: 75% (9/12) | 53% (n = 10) neutropenia, 42% (n = 8) anemia, 26% (n = 5) infection, and 21% (n = 4) thrombocytopenia. One patient died due to CRS (grade 5) |
| NCT03287908 | AMG-701 | BCMA/CD3 | 1 | 270 patients | Recruiting | N/A | N/A |
| NCT03761108 | REGN-5458 | BCMA/CD3 | 1/2 | 74 patients | Recruiting | N/A | N/A |
| NCT04083534 | REGN-5459 | BCMA/CD3 | 1/2 | 56 patients | Recruiting | N/A | N/A |
| NCT04108195 | JNJ-64007957 JNJ-64407564 |
BCMA/CD3 GPRC5D/CD3 |
1 | 100 patients | Recruiting | N/A | N/A |
| NCT03399799 | JNJ-64407564 | GPRC5D/CD3 | 1 | 185 patients | Recruiting | N/A | N/A |
| NCT03309111 | GBR-1342 | CD38/CD3 | 1 | 125 patients | Recruiting | N/A | N/A |
| NCT03445663 | AMG424 | CD38/CD3 | 1 | 120 patients | Recruiting | N/A | N/A |
| NCT03275103 | BFCR4350A | FcRH5/CD3 | 1 | 130 patients | Recruiting | N/A | N/A |
| NCT03173430 | Blinatumomab | CD19/CD3 | 1 | 6 patients ** | Terminated | N/A | N/A |
AE—adverse event; BCMA—B-cell maturation antigen; CBR—clinical benefit rate; CR—complete remission; CRS—cytokine release syndrome; FcRH5—Fc receptor-homolog 5; GPRC5D—G-protein coupled receptor family C group 5 member D; MR—minor response; MRD—minimal residual disease; MTD—maximum tolerated dose; N/A—not available; ORR—overall response rate; PD—progressive disease; sCR—stringent complete response; SD—stable disease; * as of 1 May 2020; ** actual enrollment.