A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCullinan Therapeutics Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 to 80 years
Active autoimmune cytopenia
Relapsed/refractory after standard of care therapy
ECOG performance status 2 or lower
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Velinotamig specified dose on specified days.
DrugVelinotamig is an engineered bispecific antibody directed against BCMA and CD3.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Part A: Dose Escalation.Experimental treatment 1 intervention
Group B: Part B: Dose Expansion.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Tolerability
Incidence and severity of all adverse events, serious adverse events, adverse events of special interest, adverse events leading to treatment discontinuation, and laboratory abnormalities.
Time frame
48 weeksSponsors and contacts
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Source ClinicalTrials.gov
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