A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA
A legfontosabb adatok
- Hol
- Webster (Egyesült Államok)A helyszín megnézése
- Fázis
- 1/2. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 80 év között vagy?
Forrás: NCT07738822: ki vehet részt
Helyszínek itt: Egyesült Államok
- Webster, TexasHospital not named in the registryContact: Cullinan Investigative SiteNo longer taking part
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Cullinan Therapeutics Inc.
- Azonosító
- NCT07738822
- A regiszteradat frissítve
- 2026. július 31.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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; 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; Planned major surgery in the timeframe of the dosing period; 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; Presence of New York Heart Association class III or IV congestive heart; Primary immunodeficiency or history of recurrent infections; History of solid organ transplant; Pregnant or lactating women.