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

NCT07714512 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-07-20

No results posted yet for this study

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.

Conditions

  • Aplastic Anemia

Interventions

DRUG

Isatuximab

Phase I: Eligible subjects will receive isatuximab at 5 mg/kg per dose or 10 mg/kg per dose. The treatment period will last 6 weeks. Isatuximab will be administered by intravenous infusion once weekly (QW) for six consecutive doses. Phase II: Eligible subjects will receive isatuximab by intravenous infusion once weekly for six consecutive doses. The specific dose will be the recommended phase II dose from the phase I part.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Jun Shi, PhD · Institute of Hematology & Blood Diseases Hosptial, Chinese Academy of Medical Science and Peking Union Medical School

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-06-30
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07714512 on ClinicalTrials.gov