Table 2.
BiTE clinical trials
| Trial | Structure | Outcomes | Adverse effects | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Agent | Trial ID + references | Status | Phase | Study population | Enrollment (N) | MM Cell target | T Cell Ligand | ORR (%) | MEDIAN PFS (months) | Grade ≥ 3 CRS (%) | Grade 3 NTX (%) |
|
AMG 420 (pacanalotamab, BI 836,909) |
NCT03836053 | Active, not recruiting | 1 | RRMM | 47 | BCMA | CD3 | NA | NA | NA | NA |
|
AMG 420 (pacanalotamab, BI 836,909) |
[132] |
Completed | 1 | RRMM | 42 | BCMA | CD3 | 70 | 23.5 | 2 | 4 |
| AMG 701 (pavurutamab) |
(ProxiMMity-1) |
Not yet recruiting | 1 | RRMM | 47 | BCMA | CD3 | NA | NA | NA | NA |
|
elranatamab (PF-06863135) |
NCT03269136 (MagnetisMM-1) [133] |
Active, not recruiting | 1 | RRMM | 90 | BCMA | CD3 | 75 | Not published | 0 | 0 |
|
elranatamab (PF-06863135) |
NCT04798586 (MagnetisMM-2) | Active, not recruiting | 1 | RRMM | 4 | BCMA | CD3 | NA | NA | NA | NA |
|
teclistamab (JNJ-64007957) |
(MajesTEC-1) [134] |
Recruiting | 1 | RRMM | 204 | BCMA | CD3 | 67 | Not published | 0 | 3 |
|
teclistamab (JNJ-64007957) + anticancer drugs |
NCT04722146 | Recruiting | 1 | RRMM | 140 | BCMA | CD3 | NA | NA | NA | NA |
| teclistamab and talquetamab |
(RedirecTT-1) |
Recruiting | 1 | RRMM | 56 | BCMA and GPRC5D | CD3 | NA | NA | NA | NA |
|
teclistamab (or talquetamab) + daratumumab |
(TRIMM-2) [135] |
Recruiting | 1 | RRMM | 200 | BCMA or GPRC5D | CD3 | 78 | Not published | 0 | 0 |
|
alnuctamab (CC-93269, EM901) |
[136] |
Recruiting | 1 | RRMM | 175 | BCMA | CD3 | 83 | Not published | 5 | 0 |
| TNB-383B |
[137] |
Recruiting | 1 | RRMM | 169 | BCMA | CD3 | 52 | Not published | 0 | 0 |
| WVT078 | NCT04123418 | Recruiting | 1 | RRMM | 90 | BCMA | CD3 | NA | NA | NA | NA |
| REGN5458 | NCT05137054 | Not yet recruiting | 1 | RRMM | 256 | BCMA | CD3 | NA | NA | NA | NA |
|
teclistamab (JNJ-64007957) |
NCT04696809 | Recruiting | 1/2 | RRMM | 33 | BCMA | CD3 | NA | NA | NA | NA |
|
AMG 701 (pavurutamab) + pomalidomide |
[138] |
Recruiting | 1/2 | RRMM | 408 | BCMA | CD3 | 82 | Not published | 7 | 0 |
|
elranatamab (PF-06863135) + gamma-secretase inhibitor |
NCT05090566 (MagnetisMM-4) | Recruiting | 1/2 | RRMM | 65 | BCMA | CD3 | NA | NA | NA | NA |
|
elranatamab (PF-06863135) |
(MagnetisMM-9) |
Recruiting | 1/2 | RRMM | 76 | BCMA | CD3 | NA | NA | NA | NA |
| REGN5458 |
[139] |
Recruiting | 1/2 | RRMM | 292 | BCMA | CD3 | 60 | Not published | 0 | 0 |
| REGN5459 | NCT04083534 | Active, not recruiting | 1/2 | RRMM | 43 | BCMA | CD3 | NA | NA | NA | NA |
| EMB-06 | NCT04735575 | recruiting | 1/2 | RRMM | 66 | BCMA | CD3 | NA | NA | NA | NA |
|
teclistamab (JNJ-64007957) |
(MajesTEC-1) [140] |
Recruiting | 2 | RRMM | 192 | BCMA | CD3 | 65 | Not yet reached | 0 | 0 |
|
elranatamab (PF-06863135) |
(MagnetisMM-3) |
Active, not recruiting | 2 | RRMM | 180 | BCMA | CD3 | NA | NA | NA | NA |
|
elranatamab (PF-06863135) |
(MagnetisMM-8) |
Recruiting | 2 | RRMM | 36 | BCMA | CD3 | NA | NA | NA | NA |
| talquetamab (JNJ-64407564) |
[75] |
Recruiting | 1 | RRMM | 260 | GPRC5D | CD3 | 63 | Not yet published | 4 | 0 |
|
talquetamab (JNJ-64407564) + anticancer drugs |
NCT05050097 | Recruiting | 1 | RRMM | 176 | GPRC5D | CD3 | NA | NA | NA | NA |
| talquetamab (JNJ-64407564) | NCT04773522 | Recruiting | 1 | RRMM | 9 | GPRC5D | CD3 | NA | NA | NA | NA |
| talquetamab (JNJ-64407564) | NCT04634552 | Recruiting | 2 | RRMM | 320 | GPRC5D | CD3 | NA | NA | NA | NA |
| blinatumomab | NCT03173430 | Terminated | 1 | RRMM | 6 | CD19 | CD3 | NA | NA | NA | NA |
| AMG 424 | NCT03445663 | Terminated | 1 | RRMM | 27 | CD38 | CD3 | NA | NA | NA | NA |
| Y150 | NCT05011097 | Recruiting | 1 | RRMM | 75 | CD38 | CD3 | NA | NA | NA | NA |
|
GBR1342 (ISB 1342) |
NCT03309111 | Recruiting | 1 | RRMM | 197 | CD38 | CD3 | NA | NA | NA | NA |
| cevostamab (BFCR4350A, RG6160) |
(CAMMA 1) |
Recruiting | 1 | RRMM | 120 | FcRH5 | CD3 | NA | NA | NA | NA |
| cevostamab (BFCR4350A, RG6160) |
NCT03275103 (GO39775) [141] |
Recruiting | 1 | RRMM | 300 | FcRH5 | CD3 | 52 | Not yet reached | 2 | 0 |
RRMM = relapsed/refractory MM, ORR = overall response rate, PFS = progression-free survival, CRS = cytokine release syndrome, NTX = neurotoxicity