ClinicalTrials.gg
Not yet recruitingNCT07788469Updated Aug 26, 2026

A Study of Elranatamab for Inhibitor Eradication in Patients With Hemophilia A

An interventional study of Elranatamab in Hemophilia A With Inhibitors, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies in Hemophilia A by Institute of Hematology & Blood Diseases Hospital, China — 11 open to participants now, 12 under way, none of them phase 3. Hemophilia A · Institute of Hematology & Blood Diseases Hospital, China.

Started
2026
with 2 others
No phase
3 of 13
3 open now
Primary completion
2027-10
later than 8 of 11 live
Registered
13th of 13
by date

Among the 13 studies in Hemophilia A by Institute of Hematology & Blood Diseases Hospital, China, this one is one of 3 that started in 2026, is one of 3 with no phase, reaches primary completion later than 8 of the 11 other live ones, and was the 13th registered.

Hemophilia A

844 studies on the registry are indexed under Hemophilia A; 136 are open to participants now.

Browse Hemophilia A studies →

Open to participants now

11 of the 13 studies in Hemophilia A by Institute of Hematology & Blood Diseases Hospital, China are open now, in 1 country. Recruiting first, the newest first:

5 more — sign in →

By country, each count listing its studies:

All 11 open studies →

Where they have run

Who these studies take

Of the 86 Hemophilia A studies recruiting now, 51 (59%) set no upper age limit and 30 (35%) stop at 75 or younger; 54 take children under 18; 10 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Hemophilia A by Institute of Hematology & Blood Diseases Hospital, China, or all of them as a file.
02

Study 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 \<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.

03

Conditions studied

  • Hemophilia A With Inhibitors

Browse trials for

Keywords

  • Hemophilia A
  • Inhibitors
  • Elranatamab
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Known to Elranatamab or any of its .
  • Presence of other diseases or a need for therapy for reasons unrelated to this study.
  • History of within 5 years prior to screening, with the exception of adequately treated carcinoma in situ of the cervix or non- 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.
  • laboratory abnormalities at screening, including:

    1. (ALT) or aspartate aminotransferase (AST) >3 × the (ULN).
    2. Total >1.5 × ULN (subjects with documented Gilbert syndrome are not excluded based on this criterion);
    3. \<1,500/mm³;
    4. \<9 g/dL or immunoglobulin G (IgG) \<500 mg/dL;
    5. Absolute lymphocyte count \<500/mm³;
    6. (CrCl) \<30 mL/min.
  • Positive test for antibody or syphilis antibody.
  • Positive surface antigen (HBsAg); or positive hepatitis B core antibody (anti-HBc) with detectable HBV DNA by polymerase chain reaction (PCR). Subjects positive for virus (HCV) antibody are excluded.
  • 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.
  • Subjects with psychiatric disorders that impair their ability to provide or comply with study procedures and follow-up.
  • Subjects with unresolved toxicities from prior therapies before study participation.
  • Any other condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    hemophilia A with inhibitors receiving Elranatamab at a stepwise dose-escalation regimen

    Elranatamab will be administered with a stepwise dose-escalation regimen

    Drug: Elranatamab

Interventions

  • Patients receive Elranatamab at 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. If the inhibitor titer decreases by \>20% from baseline at Week 3, no further treatment will be given, and patients will proceed directly to follow-up.

06

What researchers measure

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (AES)

    AES was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.

    Time frame: 1 year

Secondary outcomes

  1. The proportion of patients who achieve successful inhibitor eradication

    the number of patients with successful inhibitor eradication divided by the total number of patients in the study, expressed as a percentage.

    Time frame: 1 year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — Data can be requested from the corresponding authors from 12 months to 36 months after study completion

Supporting information: Study protocol

Time frame: from 12 months to 36 months after study completion

Access criteria: From corresponding author

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

Of 72 non-industry interventional studies with no phase under Hemophilia A, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 38. This study's planned 12 months is close to that.

Counting every sponsor, half of 75 studies reached it within 11 months; a quarter within 5 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2026
First posted
Aug 26, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2027
CompletionEst.
Oct 2028
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07788469
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Oct 2028 (estimated)
Last update
Aug 26, 2026

Study contacts

Wei Liu
Contact
liuwei1@ihcams.ac.cn
+8613820261971
Lei Zhang
Contact
zhanglei1@ihcams.ac.cn
Lei Zhang
principal investigator · Chinese Academy of Medical Science and Blood Disease Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Elranatamab

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