Table 4 BCMA-targeted bispecific T cell engagers in clinical trials

AMG 420 (Amgen)

BCMA/CD3

Phase 1 NCT02514239

[72]

R/R MM who received or were refractory to ≥ 2 prior lines, including PI and IMiD; PC leukemia, extra-medullary relapse, CNS involvement, or prior ASCT were excluded

42 pts;

median age 65;

median prior lines 4

0.2–800 μg/d, 4 wks infusion +2 wks off, for up to 5 cycles.

Avg 2.5 ± 2.6 cycles

ORR 31%;

sCR 14%,

CR 7%,

VGPR 4.8%,

PR 4.8%

G3+ infection 12 (28.5%), polyneuropathy 2 (4.8%); G2–3 CRS 3 (7%); DLT 3 (7%)

CC-93269 (Celgene)

BCMA (bivalent)/CD3 (monovalent)

Phase 1 NCT03486067

[167]

R/R MM who received or were refractory to ≥ 3 prior lines; hx of BCMA-directed therapy were excluded

19 pts;

median age 64;

median prior lines 6;

ASCT 16 (84%); all pts refractory to the last line

0.15–10 mg/d for a 28-day cycle (D1, 8, 15, and 22 for Cycles 1–3; D1 and 15 for Cycles 4–6; and on D1 for Cycle 7).

Median 4 cycles; Median DOT 14.6 wks

12 pts w/ dose of ≥ 6 mg;

ORR 10 (83.3%); sCR/CR 4 (33.3%), VGPR 7 (58.3%)

G3+ neutropenia (52.6%), anemia (42.1%), infections (26.3%), thrombocytopenia (21.1%);

G1–2 CRS 17 (89.5%)

PF-06863135 (Pfizer)

BCMA/CD3, IgG2a backbone

Phase 1 NCT03269136

[168]

R/R MM who received or were refractory to ≥ 3 prior lines, including PI, IMiD, CD38 mAb

17 pts;

median age 61;

median prior lines 11;

5 pts (29%) had prior BCMA-targeted therapy

Once weekly non-continuous infusion in 6 dose-escalation groups

Minimal response 1 (6%); SD 6 (35%); PD 9 (53%)

G3+ thrombocytopenia (24%), anemia (18%);

G1–2 CRS (24%)

REGN5458 (Regeneron)

BCMA/CD3

Phase 1 NCT03761108 [169]

R/R MM who received or were refractory to ≥3 prior lines, including PI, IMiD, CD38 mAb

7 pts

6 mg/kg, 16 weekly doses + maintenance 12 doses per 2 wks

ORR 4 (53.3%)

G1–2 CRS 3 (42.9%)

AMG 701 (Amgen)

BCMA/CD3, extended half-life

Phase 1 NCT03287908

R/R MM who received or were refractory to ≥ 3 prior lines, including PI, IMiD, CD38 mAb

–

–

–

–

TNB383B (TeneoBio)

BCMA (high affinity)/CD3 (low affinity), IgG4 backbone

Phase 1 NCT03933735

R/R MM who received or were refractory to ≥ 3 prior lines, including PI, IMiD, CD38 mAb

–

–

–

–