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New combo aims to fight relapsed leukemia after transplant

NCT ID NCT05772273

Disease control Sponsor: The First Affiliated Hospital of Soochow University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This study tests a combination of a PD-1 inhibitor (camrelizumab), a chemotherapy drug (azacitidine), and donor immune cells (DLI) in 43 adults with acute myeloid leukemia that has returned after a stem cell transplant. The goal is to see if this approach can help patients achieve remission again. The trial is currently recruiting participants aged 18 to 60 with adequate organ function.

What this could mean

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

Active substance
Camrelizumab (PD-1 inhibitor), azacitidine, and donor lymphocyte infusions
What this could lead to
If successful, this combination could offer a new treatment option for patients whose AML returns after a stem cell transplant, potentially improving remission rates.
What could go wrong
This is a small, early-phase study with only 43 participants, so results may not apply widely. The combination also carries risks like graft-versus-host disease and immune-related side effects.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 43 people

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

Started

Mar 2023

Expected to finish

Dec 2027

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Patients with a diagnosis of AML relapse after allogeneic hematopoietic stem cell transplantation. 2. Adequate organ function. 3. Be able to understand and sign informed consent. 4. Age 18 to 60 years old. 5. Serum pregnancy test for females of childbearing potential that is negative within one week prior to initiation of first dose of treatment. Female patients of childbearing potential and sexually active males must agree to use a highly effective method of contraception throughout the study and for at least 90 days after the last dose of assigned treatment. 6. ECOG performance status ≤ 1. 7. Known HLA-matched donor without contraindications to donate. 8. Life expectancy \> 3 months. Exclusion Criteria: 1. Diagnosis of anther malignant disease. 2. Suspected or proven acute or chronic GVHD. 3. Proven central nervous system leukemia. 4. Prior treatment with anti-PD-1, anti-PD-L1, or DLI. 5. HLA loss positive. 6. Known active viral infection with known human immunodeficiency virus (HIV) or viral hepatitis type B (HBV) or C (HCV) or Corona Virus Disease 2019(COVID-19); 7. Uncontrolled systemic fungal, bacterial, or viral infection. 8. Known or suspected hypersensitivity to PD-1 inhibitor or azacytidine. 9. Participation in another clinical study within 3 months. 10. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study procedures.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

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

Acute myeloid leukemia

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.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

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