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Experimental cell therapy targets stubborn leukemia in early trial

NCT ID NCT05654779

Disease control Sponsor: Institute of Hematology & Blood Diseases Hospital, China Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a new treatment called LCAR-AMDR cells in 4 people with acute myeloid leukemia that had come back or not responded to standard therapy. The treatment uses specially engineered immune cells to target two proteins (CLL1 and CD33) on leukemia cells. The main goals were to check safety and find the right dose. The study was terminated early, so results are limited.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

4 people

The number who actually took part.

Started

Dec 2022

Finished

Sep 2023

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

14 to 60 years

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. The subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF)（For minors, the guardian shall also provide written informed consent ）; Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease; 2. Age 14-60 years; 3. ECOG score: ≤2; 4. Relapsed/refractory AML must meet one of the following conditions: 1. Twice or more relapse; 2. Newly diagnosed AML patients who failed after 2 cycles of standard chemotherapy; 3. Relapse within 12 months after CR, or relapse after 12 months with CR but failed to respond to conventional chemotherapy; 4. Persistent extramedullary leukemia. 5. Meet the requirements of allogeneic HSCT 6. Expected survival ≥ 3 months; Exclusion Criteria: 1. Subject with APL/AML-M3:t(15;17)(q22;q12) 2. Received any of the following treatments: * Previous allo-HSCT(Subjects who received allo-HSCT for more than 6 months, have stopped immunosuppressive drugs and have no active GvHD are not included in the exclusion criteria) * Previous gene therapy * Previous anti CD33/CLL1 therapy * Previous any target CAR-T cells therapy 3. Prior antitumor therapy with insufficient washout period; 4. CNS infiltration; Except for patients with prior CNS infiltration who are currently in remission; 5. HBsAg, HBV DNA, HCV-Ab, HCV RNA or HIV-Ab positive; 6. Pregnant or breast-feeding women;

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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

Contacts and locations

Locations

  • Beijing Gobroad BoRen Hospital

    Beijing, Beijing Municipality, 100070, China

  • Chinese Academy of Medical Science and Blood Disease Hospital

    Tianjin, Tianjin Municipality, 300020, China

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