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

Starting soon · Phase 1/Phase 2

Conditions studied: Immune Thrombocytopenia (ITP), Warm Autoimmune Hemolytic Anemia (WAIHA)

In brief

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 facts

Study ID

NCT07738822

Run by

Cullinan Therapeutics Inc.

People needed

72

Starts

2026-12-01

Expected to finish

2031-01-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Epidemiology Collaboration (CKD-EPI) formula ≥30 mL/min/1.73m2

You may not qualify if…

• Pregnant or lactating women
• History of clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with subject safety, study evaluations, and/or study procedures, would put the patient at undue risk or confound study results
• Evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV), HIV, Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection
• Active or latent tuberculosis (TB) evidenced by a positive or indeterminate interferon gamma release assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB
• Presence of New York Heart Association class III or IV congestive heart
• Primary immunodeficiency or history of recurrent infections
• Previous treatment with a BCMA-targeted therapy
• Receipt of an investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1
• History of solid organ transplant
• Planned major surgery in the timeframe of the dosing period

Where it is running

• Cullinan Investigative Site — Webster, Texas, United States

Full record on ClinicalTrials.gov

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