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Acute Myeloid LeukemiaPhase 1NCT05654779

CLL-1/CD33 Targeted LCAR-AMDR Cells in Patients With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1 study testing LCAR-AMDR Cells Product in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 2 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a prospective, single-arm, open-label, single dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-AMDR cells in subjects with relapsed/refractory Acute Myeloid Leukemia who received adequate standard therapy. Read more about this study

Who is it for?
Ages 14 to 60 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
LCAR-AMDR Cells Product
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
2 sitesChina
Study dates
12 Dec 2022to 26 Sep 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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;
  • Age 14-60 years;
  • ECOG score: ≤2;
  • Relapsed/refractory AML must meet one of the following conditions:
  • Twice or more relapse;
  • Newly diagnosed AML patients who failed after 2 cycles of standard chemotherapy;
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  • Relapse within 12 months after CR, or relapse after 12 months with CR but failed to respond to conventional chemotherapy;
  • Persistent extramedullary leukemia.
  • Meet the requirements of allogeneic HSCT
  • Expected survival ≥ 3 months;

Who cannot join

  • Subject with APL/AML-M3:t(15;17)(q22;q12)
  • 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
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  • Prior antitumor therapy with insufficient washout period;
  • CNS infiltration; Except for patients with prior CNS infiltration who are currently in remission;
  • HBsAg, HBV DNA, HCV-Ab, HCV RNA or HIV-Ab positive;
  • Pregnant or breast-feeding women;

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Gobroad BoRen Hospital

    Beijing, Beijing Municipality, 100070

  • Chinese Academy of Medical Science and Blood Disease Hospital

    Tianjin, Tianjin Municipality, 300020

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of CLL1-/CD33 Targeted LCAR-AMDR Cells Product in Patients With Relapsed/Refractory Acute Myeloid Leukemia

This is a prospective, single-arm, open-label, single dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-AMDR cells in subjects with relapsed/refractory Acute Myeloid Leukemia who received adequate standard therapy.

Being tested
LCAR-AMDR Cells Product
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LCAR-AMDR Cells ProductBiological

    Subjects will receive a conditioning regimen before treatment with LCAR-AMDR cells

Study groups in NCT05654779
Study groupRoleWhat they receive
LCAR-AMDR Cells ProductExperimentalEach subject will be treated with LCAR-AMDR Cells
Receives: Biological: LCAR-AMDR Cells Product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

    An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment

    Measured: Time Frame: Minimum 2 years after LCAR-AMDR infusion (Day 1)

  2. Recommended Phase 2 dose (RP2D) finding

    RP2D established through ATD+BOIN design

    Measured: 30 days after LCAR-AMDR infusion (Day 1)

  3. CAR positive T cells and CAR transgene levels in peripheral blood and bone marrow

    CAR positive T cells and CAR transgene levels in peripheral blood and bone marrow after LCAR-AMDR infusion

    Measured: 2 years after LCAR-AMDR infusion (Day 1)

Secondary outcomes (7)

  1. Overall response rate (ORR)

    Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or CRi after treatment via LCAR-AMDR cell infusion

    Measured: 2 years after LCAR-AMDR infusion (Day 1)

  2. Time to Response (TTR)

    Time to Response (TTR) is defined as the time from the date of first infusion of LCAR-AMDR to the date of the first response evaluation of the subject who has met all criteria for CR or CRi.

    Measured: 2 years after LCAR-AMDR infusion (Day 1)

  3. Duration of Response (DoR)

    Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or CRi) to the first documented relapse evidence of the responders

    Measured: Minimum 2 years after LCAR-AMDR infusion (Day 1)

  4. Event-free survival (EFS)

    Event-free survival (EFS) is defined as the time from the date of first infusion of the LCAR-AMDR to the first documented treatment failure, disease relapse or death (due to any cause), whichever occurs first

    Measured: Minimum 2 years after LCAR-AMDR infusion (Day 1)

  5. Overall Survival (OS)

    Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-AMDR to death of the subject

    Measured: Minimum 2 years after LCAR-AMDR infusion (Day 1)

  6. The proportion of subjects who achieve CR or Cri and obtain bone marrow MRD negative.

    The proportion of subjects who achieve CR or Cri and obtain bone marrow MRD negative.

    Measured: Minimum 2 years after LCAR-AMDR infusion (Day 1)

  7. Incidence of anti-LCAR-AMDR antibody and positive sample titer

    Venous blood samples will be collected to measure LCAR-AMDR positive cell concentrations and the transgenic level of LCAR-AMDR, at the time points when anti-LCAR-AMDR antibody serum samples are evaluated

    Measured: Minimum 2 years after LCAR-AMDR infusion (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2022
  2. Study start12 Dec 2022
  3. Primary completion26 Sep 2023
  4. Study completion26 Sep 2023

Why it stopped: Both the sponsors and collaborator are considering terminating the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05654779
Sponsor's protocol ID
IIT2022043
Status last verified
Feb 2026
First submitted
8 Dec 2022
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LCAR-AMDR Cells Product in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Both the sponsors and collaborator are considering terminating the study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, severity, and type of treatment-emergent adverse events (TEAEs) (time frame: Time Frame: Minimum 2 years after LCAR-AMDR infusion (Day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05654779.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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