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GR1803 vs DPd in Relapsed or Refractory Multiple Myeloma
NCT07452198Phase 3
Key facts
- Status
- Recruiting
- Start
- Mar 2026
- Primary completion
- Mar 2029
- Countries
- 1
- Sponsor
- Zhixiang Jintai
- Modality
- Prophylactic Vaccines, Bispecific Antibodies, Therapeutic Vaccines
- Drugs
- velinotamig
- Conditions
- multiple myeloma (MM)
01
Overview
Phase 3, randomised, open-label trial of velinotamig in multiple myeloma (MM) (2 arms), sponsored by Zhixiang Jintai. Primary endpoint: Progression Free Survival at 5 years. Started Mar 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
GR1803 Injection
GR1803 injection at 180 ug/kg (preceded by step-up doses of 10 and 30 ug/kg)
DPd
Daratumumab 1800 mg SC + Pomalidomide 4 mg days 1-21/28 + Dexamethasone 40 mg or 20 mg weekly
03
Who it enrols
Adults with relapsed or refractory multiple myeloma who have received 1-3 prior lines of therapy including a PI and lenalidomide, with measurable disease and ECOG PS 0-2. Excludes patients with prior BCMA-directed therapy, active CNS involvement, or who are refractory/intolerant to anti-CD38 or pomalidomide.
04
Endpoints
Primary
Progression Free Survival
Secondary
Overall Survival
Progression Free Survival on Next-line Therapy
Overall Response
Complete Response or Better
Duration of Response
Duration of Complete Response
Time to Response
Minimal Residual Disease-negativity
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