Table 2 Key trial design and patient baseline characteristics from GPRC5D-targeting trials.

From: GPRC5D as a novel target for the treatment of multiple myeloma: a narrative review

 

Talquetamaba

Forimtamigc

MCARH109

OriCAR-017

BMS-986393

Construct

GPRC5D×CD3 bispecific antibody

GPRC5D×CD3 bispecific antibody

GPRC5D-targeted CAR-T

GPRC5D-targeted CAR-T

GPRC5D-targeted CAR-T

Trial name (ClinicalTrials.gov identifier)

MonumenTAL-1 (NCT03399799/ NCT04634552)

NCT04557150

NCT04555551

NCT05016778

NCT04674813

Phase

Phase 1/2

Phase 1

Phase 1

Phase 1

Phase 1

Population size

N = 288 (n = 143 treated with 0.4 mg/kg QW SC; n = 145 treated with 0.8 mg/kg Q2W SC)b

N = 108 (n = 51 treated in IV cohort; n = 57 treated in SC cohort)

N = 17

N = 10

N = 33

Dosing

Phase 1: 0.5–180 µg/kg IV and 5–1600 µg/kg SC

Phase 2: 0.4 mg/kg QW SC or 0.8 mg/kg Q2W SC (RP2D)

18−10,000 µg IV Q2W, aside from Q3W at the 18/162/7200 μg IV dosing level

1200−7200 µg SC Q2W, aside from Q3W at the 30/150/4800 μg and 30/300/

7200 μg SC dosing level

1 infusion of 25 × 106, 50 × 106, 150 × 106, or 450 × 106 CAR-T cells

1 infusion of

1 × 106/kg, 3 × 106/kg, or 6 × 106/kg CAR-T cells

1 infusion of 25 × 106, 75 × 106, 150 × 106, 300 × 106, or 450 × 106 CAR-T cells

Last presented

Data cut-off

ASH 2022

May 16, 2022 (safety)

September 12, 2022 (efficacy)

ASH 2022

October 21, 2022

N Engl J Med 2022

June 16, 2021

Lancet Haematol 2023

June 30, 2022

ASH 2022

September 7, 2022

Dosing schedule

Step-up

SC QW/Q2W

2/3 step-up doses

IV/SC Q2W, with noted exceptions

2 step-up doses

Bridging therapy after apheresis was allowed if it was stopped ≥2 weeks before lymphodepleting chemotherapy. Patients received lymphodepleting chemotherapy with fludarabine (30 mg/m2/d) and cyclophosphamide (300 mg/m2/d) for 3 days. Two days after lymphodepletion, patients received a single MCARH109 infusion

Prior BCMA and bridging treatments were allowed. Patients received lymphodepleting chemotherapy with fludarabine (30 mg/m2/d) and cyclophosphamide (300 mg/m2/d) for 3 days followed by a single infusion of OriCAR-017

Prior BCMA-directed therapies were allowed, including CAR-T therapy. Patients received lymphodepleting chemotherapy with fludarabine (30 mg/m2/d) and cyclophosphamide (300 mg/m2/d) for 3 days followed by a single infusion of BMS-986393

Median follow-up (range)

14.9 mo (0.5–29.0)/

8.6 mo (0.2–22.5)

11.6 mo (0.5–20.6)/8.0 mo (1.1–15.0)

10.1 mo (8.5–NE)

238 days

(182–307d)

5.8 mo (1.0–15.5)

Median prior lines (range)

5 (2–13)/5 (2–17)

5 (2–15)/4 (2–14)

6 (4–14)

5.5 (4–10d)

4 (3–13)

Triple-class refractory

106 (74%)/100 (69%)

31 (62%)/41 (72%)

16 (94%)

N/R

N/R

Penta-drug refractory

42 (29%)/34 (23%)

18 (36%)/24 (42%)

N/R

N/R

N/R

  1. BCMA B-cell maturation antigen, CAR-T chimeric antigen receptor T cell, GPRC5D G protein–coupled receptor family C group 5 member D, IV intravenous, mo months, NE not estimable, N/R not reported, Q3W every 3 weeks, Q2W every other week, QW weekly, RP2D recommended phase 2 dose, RRMM relapsed/refractory multiple myeloma, SC subcutaneous.
  2. aData presented are for the 0.4 mg/kg and 0.8 mg/kg groups.
  3. bAll patients were treated with the R2PD.
  4. cData presented are for the IV and SC cohorts.
  5. dData are interquartile ranges.
Back to article page