A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA

Part of paid clinical trials in Webster, Texas.

Sponsor
Cullinan Therapeutics Inc.
Study ID
NCT07738822
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Immune Thrombocytopenia (ITP)
  • Warm Autoimmune Hemolytic Anemia (WAIHA)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Velinotamig specified dose on specified days. — DRUG
    Velinotamig is an engineered bispecific antibody directed against BCMA and CD3.

Study Details

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.

Key Dates

First listed
Jul 31, 2026
Start date
Dec 31, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2031

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Dose Escalation.
    Patients with relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia with velinotamig in dose escalation cohorts.
  • Experimental: Part B: Dose Expansion.
    Patients with relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia with velinotamig in dose expansion cohorts.

Primary Outcome Measure

Safety and Tolerability [ Time Frame: 48 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cullinan Investigative SiteWebsterTexas77598
Cullinan Investigative Site
[email protected]
+6178609878

Find similar trials in Webster, TX

By research site
Cullinan Investigative Site· Webster, TX

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