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Not Yet Recruiting 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 \

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Source: ClinicalTrials.gov (NCT07788469). StuddyBuddy aggregates publicly available trial information.