A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Velinotamig specified dose on specified days..
- Who it may be relevant to
- Registry conditions: Immune Thrombocytopenia (ITP), Warm Autoimmune Hemolytic Anemia (WAIHA). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Velinotamig specified dose on specified days.
Velinotamig is an engineered bispecific antibody directed against BCMA and CD3.
Primary outcome measures
- Safety and Tolerability [Time frame: 48 weeks]
Eligibility criteria
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 Epidemiology Collaboration (CKD-EPI) formula ≥30 mL/min/1.73m2
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cullinan Investigative Site — Webster
Identifiers
NCT: NCT07738822 · CLN-803-AIC-101