Clinical Trial: Phase I/II Study of Anti-CD38 Monoclonal Antibody in Refractory Severe Aplastic Anemia

U.S., July 21 -- ClinicalTrials.gov registry received information related to the study (NCT07714512) titled 'Phase I/II Study of Anti-CD38 Monoclonal Antibody in Refractory Severe Aplastic Anemia' on July 15.

Brief Summary: This is a phase I/II clinical study in adult patients with refractory severe aplastic anemia (SAA). Eligible patients must meet the criteria for refractory SAA and have a platelet count (PLT) <30 x 10^9/L and/or hemoglobin (HGB) <90 g/L at enrollment. If the phase I results demonstrate an acceptable safety profile and allow determination of the maximum tolerated dose (MTD), the phase II part will be initiated directly to evaluate the efficacy of isatuximab.

Study Start Date: June 30

Study Type: INTERVENTIONAL

Conditi...