drugset / Trial / NCT07714512
Phase I/II Study of Anti-CD38 Monoclonal Antibody in Refractory Severe Aplastic Anemia
Phase 1/2
Recruiting
32 enrolled
Institute of Hematology & Blood Diseases Hospital, China
Sanofi · collab
NaSingle-groupOpen-labelTreatment
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 × 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.
Timeline
- Start
- 2026-06-30
- Primary completion
- 2028-06-30
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isatuximab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Isatuximab | Monoclonal antibody | 10 mg/kg | Intravenous |