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NCT07788469
A Study of Elranatamab for Inhibitor Eradication in Patients With Hemophilia A
Conditions: Hemophilia A With Inhibitors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Location: Chinese Academy of Medical Science and Blood Disease Hospital Tianjin
Summary
This is a prospective, single-arm, open-label, exploratory clinical study designed to evaluate the safety and efficacy of Elranatamab for inhibitor eradication in adults with moderate-to-severe hemophilia A with inhibitors. A total of 15-20 patients aged ≥18 years will be enrolled. Elranatamab will be administered with a stepwise dose-escalation regimen of 12 mg on Day 1 and 32 mg on Day 4 during Week 1, followed by the target dose of 38 mg once weekly during Weeks 2-3. Patients will then enter a 4-week follow-up period. If the inhibitor titer decreases by \
Eligibility Criteria
Inclusion Criteria:
* Male or female patients with moderate-to-severe hemophilia A (factor VIII activity \0.6 BU/mL).
* Baseline factor VIII inhibitor titer \>10 BU/mL at the time of enrollment.
Exclusion Criteria:
* Known hypersensitivity to Elranatamab or any of its excipients.
* Presence of other autoimmune diseases or a need for immunosuppressive therapy for reasons unrelated to this study.
* History of malignancy within 5 years prior to screening, with the exception of adequately treated carcinoma in situ of the cervix or non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma.
* History of severe recurrent or chronic infections, or acute infection requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungal agents within 4 weeks before the first dose or during the screening period, or superficial skin infection requiring systemic therapy within 1 week before the first dose.
* Clinically significant laboratory abnormalities at screening, including:
1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × the upper limit of normal (ULN).
2. Total bilirubin \>1.5 × ULN (subjects with documented Gilbert syndrome are not excluded based on this criterion);
3. Absolute neutrophil count \
Source: ClinicalTrials.gov (NCT07788469). StuddyBuddy aggregates publicly available trial information.