NCT07788469Not yet recruiting
A Study of Elranatamab for Inhibitor Eradication in Patients With Hemophilia A
A Single-Arm, Open-Label, Exploratory Clinical Study to Evaluate the Safety and Efficacy of Elranatamab for Inhibitor Eradication in Patients With Moderate-to-Severe Hemophilia A With Inhibitors and Poor Prognosis for Inhibitor Eradication
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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 \<20% from baseline at Week 3, two additional weekly doses of 38 mg may be administered before follow-up. Treatment response will be assessed according to changes in inhibitor titers following treatment.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 21 Jul 2026
- Start date
- Oct 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Haemophilia
- NCT number
- NCT07788469
What you commit to
- Study type: Interventional
- Planned participants: 20
- From Oct 2026 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Subjects with unresolved toxicities from prior therapies before study participation.
Other illness
- 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.
- Positive test for HIV antibody or syphilis antibody.
- Positive hepatitis B surface antigen (HBsAg); or positive hepatitis B core antibody (anti-HBc) with detectable HBV DNA by polymerase chain reaction (PCR). Subjects positive for hepatitis C virus (HCV) antibody are excluded.
- Subjects with psychiatric disorders that impair their ability to provide informed consent or comply with study procedures and follow-up.
- Any other condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
Lab values
- Clinically significant laboratory abnormalities at screening, including:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × the upper limit of normal (ULN).
- Total bilirubin \>1.5 × ULN (subjects with documented Gilbert syndrome are not excluded based on this criterion);
- Absolute neutrophil count \<1,500/mm³;
- Hemoglobin \<9 g/dL or immunoglobulin G (IgG) \<500 mg/dL;
- Absolute lymphocyte count \<500/mm³;
- Creatinine clearance (CrCl) \<30 mL/min.
Other
- Women who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study; men whose partners plan to become pregnant during the study.
Who the study is looking for
- Male or female patients with moderate-to-severe hemophilia A (factor VIII activity \<2%).
- Aged 18 to 65 years, inclusive.
- Positive factor VIII inhibitor detected on at least two consecutive occasions (inhibitor titer \>0.6 BU/mL).
- Baseline factor VIII inhibitor titer \>10 BU/mL at the time of enrollment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese Academy of Medical Science and Blood Disease Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.