Could a cancer antibody reboot blood production in aplastic anemia?

NCT ID NCT07714512

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Sep 21, 2026 · Updated 2 times

Summary

This trial tests isatuximab, an antibody that targets CD38, in adults with refractory severe aplastic anemia—a condition where the bone marrow fails to produce enough blood cells. Participants receive weekly infusions for six weeks. The study aims to see if the drug is safe and can improve blood cell counts in patients who have not responded to standard treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a CD38 monoclonal antibody called isatuximab
What this could lead to
If successful, this could offer a new treatment option for patients with severe aplastic anemia who do not respond to current therapies.
What could go wrong
This is an early-phase trial with only 32 participants, so results may not generalize. The drug may cause side effects or fail to improve blood counts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosed with primary acquired aplastic anemia according to the 2024 British Society for Haematology guideline, Guidelines for the Diagnosis and Management of Adult Aplastic Anaemia, and the Chinese Guideline for the Diagnosis and Treatment of Aplastic Anemia (2022 edition) issued by the Hematology Branch of the Chinese Medical Association. * Previously diagnosed with severe aplastic anemia (SAA) or very severe aplastic anemia (VSAA), with no response or relapse after receiving anti-thymocyte/anti-lymphocyte globulin (ATG/ALG) in combination with standard-dose cyclosporine for at least 6 months, and standard-dose thrombopoietin receptor agonist (TPO-RA) therapy for at least 4 months. * Hemoglobin \<90 g/L or platelet count \<30×10\^9/L * Unsuitable for or unwilling to undergo hematopoietic stem cell transplantation, with no better available treatment options. * Age ≥18 years, regardless of gender. * Eastern Cooperative Oncology Group (ECOG) performance status score ≤2 * Willing and able to comply with the requirements for this study and written informed consent. Exclusion Criteria: * Diagnosed with congenital bone marrow failure syndromes * Bone marrow reticulin fibrosis grade ≥2 * Subjects with a paroxysmal nocturnal hemoglobinuria (PNH) clone ≥50% or active hemolysis * Subjects with clonal cytogenetic abnormalities characteristic of myelodysplastic syndromes, except +8, del(20q), and -Y * Active bacterial, viral, or fungal infection within 2 weeks before the first dose of the investigational drug, excluding common cold and onychomycosis, or any other serious infection. Any anti-infective treatment course for infection must have been completed at least 2 weeks before the first dose. Subjects with a history of HIV infection or positive HIV antibody during screening; positive Treponema pallidum antibody during screening; active tuberculosis, defined as chest imaging or other relevant examinations within 3 months before the first dose of the investigational drug or during screening suggesting active tuberculosis infection; or active hepatitis during screening, defined as hepatitis B surface antigen (HBsAg) positivity, or hepatitis B core antibody (HBcAb) positivity with hepatitis B virus (HBV) DNA ≥30 IU/mL, or hepatitis C virus (HCV) antibody positivity with HCV RNA positivity * Active bleeding in the gastrointestinal tract, respiratory tract, central nervous system, or other sites * A history of any clinically significant disease that, in the investigator's opinion, would pose a safety risk to the subject if participating in the study, or would affect the evaluation of efficacy or safety if the disease/condition worsens during the study, including but not limited to: a. cardiovascular diseases, such as a history of acute myocardial infarction or unstable angina within the past year, severe arrhythmia such as frequent multifocal premature ventricular contractions, ventricular tachycardia, or ventricular fibrillation, congestive heart failure, arterial or venous thrombosis, or New York Heart Association (NYHA) class III-IV cardiac function; b. a history of psychiatric disorders, severe cerebrovascular disease, or cognitive sequelae * Use of agents targeting B cells or plasma cells within 3 months before the first dose of the investigational drug or anticipated use during the clinical trial * Treatment with anti-lymphocyte globulin or anti-thymocyte globulin within 6 months before the first dose of the investigational drug * Treatment with tacrolimus, sirolimus, cyclophosphamide, anti-CD52 monoclonal antibody, or similar therapies within 4 weeks or 5 half-lives, whichever is shorter, before the first dose of the investigational drug * Planned participation in another clinical trial, or prior exposure to another investigational product before the first dose, with an interval of less than 4 weeks or 5 half-lives of the drug, whichever is shorter * Receipt of a live attenuated vaccine within 4 weeks before the first dose of the investigational drug or planned receipt during the study, or receipt of a COVID-19 vaccine within 7 days before dosing * Prior treatment targeting CD38 * Women who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study * Patients considered to be ineligible for the study by the investigator for reasons other than the above

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Red Blood Cell Diseases Center and Regenerative Medicine Center

    RECRUITING

    Tianjin, Tianjin Municipality, 301617, China

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