A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA
NCT07738822 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2026-07-31
Summary
A Phase 1b/2a, open-label dose escalation and dose expansion study of subcutaneously (SC) administered velinotamig for the treatment of adults with relapsing and refractory immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA) to evaluate safety and tolerability.
Conditions
- Immune Thrombocytopenia (ITP)
- Warm Autoimmune Hemolytic Anemia (WAIHA)
Interventions
- DRUG
-
Velinotamig specified dose on specified days.
Velinotamig is an engineered bispecific antibody directed against BCMA and CD3.
Sponsors & Collaborators
-
Cullinan Therapeutics Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-12-31
- Primary Completion
- 2029-01-31
- Completion
- 2031-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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