Starting soon
Phase 1/2
A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA
Condition(s) studied
Immune Thrombocytopenia (ITP)Warm Autoimmune Hemolytic Anemia (WAIHA)
Investigational drug(s) / intervention(s)
Velinotamig specified dose on specified days.: Velinotamig is an engineered bispecific antibody directed against BCMA and CD3.
Study 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
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
Primary outcome measure(s)
- Safety and Tolerability — 48 weeks
Incidence and severity of all adverse events, serious adverse events, adverse events of special interest, adverse events leading to treatment discontinuation, and laboratory abnormalities.
Trial sites (1)
| Facility | City | Region | Status |
| Cullinan Investigative Site |
Webster |
Texas |
|
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