A Phase 1b/2a, Open-label Study of Velinotamig for the Treatment of Adults With Relapsing and Refractory Immune Thrombocytopenia and Warm Autoimmune Hemolytic Anemia
Cullinan Therapeutics Inc.
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥18 to 80 years * Active autoimmune cytopenia * Relapsed/refractory after standard of care therapy * ECOG performance status 2 or lower Laboratory parameters including the following: * Absolute lymphocyte count (ALC) ≥0.5 × 109/L * Absolute neutrophil count (ANC) ≥1.0 × 109/L * Hemoglobin ≥6.5 g/dL * Total bilirubin ≤1.5 × ULN unless related to Gilbert's syndrome * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0 × ULN, unless attributable to hemolysis * Estimated glomerular filtration rate (eGFR) based on the Chronic Kidney Disease Epidemio…
Interventions
- DrugVelinotamig specified dose on specified days.
Velinotamig is an engineered bispecific antibody directed against BCMA and CD3.
Location
- Cullinan Investigative SiteWebster, Texas