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AMLPhase 1NCT07617285

Allogeneic CAR-T(CT0890B) in NKG2DL+ R/R AML

A Phase 1 study testing CAR-T cells chimeric antigen receptor T cells in people with AML and Refractory/Relapse Acute Myeloid Leukemia, run by Peking University People's Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

A Clinical Study to Investigate the Safety and Efficacy of CT0890B in Patients with Relapsed/Refractory Acute Myeloid Leukemia. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
CAR-T cells chimeric antigen receptor T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
7 May 2026to 31 Dec 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-70 years (inclusive), male or female.
  • Relapsed or refractory acute myeloid leukemia (R/R AML) diagnosed according to the 2022 World Health Organization classification or ELN criteria, with confirmed NKG2D ligand-positive disease.
  • Bone marrow blasts ≥5% by morphology.
  • Estimated life expectancy >12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Adequate organ function without ongoing supportive care, defined as:
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  • Cardiac: left ventricular ejection fraction (LVEF) ≥50%;
  • Hepatic: ALT and AST ≤2.5 × upper limit of normal (ULN), and total bilirubin ≤2 × ULN;
  • Renal: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula);
  • Coagulation: activated partial thromboplastin time (APTT) ≤1.5 × ULN and prothrombin time (PT) ≤1.5 × ULN.
  • Renal: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula); d) Coagulation: activated partial thromboplastin time (APTT) ≤1.5 × ULN and prothrombin time (PT) ≤1.5 × ULN.

Who cannot join

  • Participants were diagnosed with acute promyelocytic leukemia (APL), BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase), central nervous system leukemia;
  • Participants with a history of epilepsy or other central nervous system disease;
  • Participants who have previously received autologous or allogeneic CAR-T therapy;
  • Participants who have received autologous stem cell transplantation or allogeneic stem cell transplantation within 12 weeks
  • Participants who have received prior immunotherapy targeting NKG2DL;
  • Participant has clinically significant active GVHD or is receiving systemic corticosteroids for GVHD;
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  • Participant has any of the following at screening:
  • 1)Active, uncontrolled systemic infection or requiring intravenous anti-infective agents 2)Any of the following cardiac conditions, including:
  • New York Heart Association Class III-IV heart failure;
  • History of myocardial infarction, coronary artery bypass grafting, or unstable angina within 6 months prior to Qinglin;
  • History of uncontrolled arrhythmia of significant clinical significance (as judged by the investigator), such as ventricular arrhythmia;
  • History of severe nonischemic ardiomyopathy;
  • Other cardiac disease that the investigatorbelieve could jeopardize the participant 's well-being or compromise participation in this clinical trial; 3) Active bleeding of clinical significance as judged by the investigator; 4)Requiring supplemental oxygen to maintain oxygen saturation> 92%; 5)Patients with severe chronic obstructive pulmonary disease (COPD) or other lung diseases that cannot tolerate CAR-T treatment as judged by the investigator;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiangyu Zhao, M.D,Ph.D contact

010-88325531

Zhao_xy@bjmu.edu.cn

Meng Lv, M.D., Ph.D contact

010-88316617

drlvmeng@bjmu.edu.cn

China1 site, 1 recruiting

  • Peking University People's Hospital

    Beijing, 100044

    Meng Lv, M.D,Ph.D, 010-88316617, drlvmeng@bjmu.edu.cn

    Xiangyu Zhao, M.D, Ph.D

    Recruiting

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Cells (CT0890B) in Patients With NKG2DL-Positive Relapsed/Refractory Acute Myeloid Leukemia

A Clinical Study to Investigate the Safety and Efficacy of CT0890B in Patients with Relapsed/Refractory Acute Myeloid Leukemia.

Read the detailed description

This is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety, efficacy, and cellular pharmacokinetics of CT0890B in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 12~27 participants in this trial.

Being tested
CAR-T cells chimeric antigen receptor T cells
Keywords
CT0890B, Universal CAR-T, AML

What participants receive

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

  • CAR-T cells chimeric antigen receptor T cellsDrug

    Also called Off-the-shelf allogeneic CAR-T cells

    Conditioning regimen:

    Days -9 to -3:

    Venetoclax administered with a target dose of 200 mg/day.

    Days -5 to -4:

    Cytarabine administered at 500 mg/m²/day.

    Days -5 to -3:

    Cyclophosphamide at 300 mg/m²/day plus Fludarabine at 30 mg/m²/day.

    Day 0:

    Infusion of CT0890B CAR-T cells at one of four dose levels using an i3+3 Dose-Escalation Design:

    1.5 × 10⁸ total cells, 3.0 × 10⁸ total cells, 4.5 × 10⁸ total cells, 6.0 × 10⁸ total cells

Study groups in NCT07617285
Study groupRoleWhat they receive
CAR-T cells chimeric antigen receptor T cellsExperimentalCT0890B cells infusion
Receives: Drug: CAR-T cells chimeric antigen receptor T cells

What is being measured

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

  1. Adverse Events (AE) after CT0890B infusion

    An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria

    Measured: 12 months after CT890B infusion

  2. Dose-limiting toxicity (DLT)

    The DLT is evaluated as the proportion of patients who experienced adverse events related to CT0890B that meet the criteria for DLT events after the first infusion

    Measured: Up to 28 days after CAR-T cells infusion

  3. MTD and/or dose range

    Evaluate Dose limited toxicity and recommended dosage range after CT0890B infusion

    Measured: Up to 28 days after CAR-T cells infusion

Secondary outcomes (11)

  1. Composite response (CRc)

    The composite response rate (CRc) included complete response (CR), complete response with partial hematologic recovery (CRh), complete response with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS). Responses were assessed in accordance with the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and the 2022 European LeukemiaNet criteria for acute myeloid leukemia (AML).

    Measured: 12 months after CT0890B infusion

  2. Partial response (PR)

    Partial response (PR) was defined and assessed according to the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and the 2022 European LeukemiaNet response criteria for AML.

    Measured: 12 months after CT0890B infusion

  3. Rate of Subsequent Stem Cell Transplantation After CAR-T Therapy

    This secondary endpoint was defined as the proportion of patients who proceeded to stem cell transplantation after CAR-T therapy during the study period.

    Measured: 12 months after CT0890B infusion

  4. Duration of response (DOR)

    Patients achieving CR, CRi, CRh, or MLFS were included in the duration of response (DOR) analysis set. DOR was defined as the time from the date of first documented response to the date of disease relapse or death from any cause, whichever occurred first.

    Measured: 12 months after CT0890B infusion

  5. Event-free survival (EFS)

    EFS was defined as the time from the date of CAR-T infusion to the earliest occurrence of treatment failure, relapse, or death from any cause. Treatment failure was defined as failure to achieve CR, CRh, CRi, MLFS, or PR at both prespecified efficacy assessments. Relapse included hematologic or extramedullary relapse after achieving CR, CRh, CRi or MLFS.

    For patients with treatment failure (ineffective therapy), the primary EFS analysis assigned an event time of 1 day (i.e., the time from infusion to treatment receipt). Sensitivity analyses were performed using alternative definitions of event timing, including the actual date of treatment failure, the end of treatment, or the initiation of subsequent anti-leukemia therapy.

    Measured: 12 months after CT0890B infusion

  6. Overall survival (OS)

    OS is defined as the time from the date of receiving the infusion to the date of death from any cause.

    Measured: 12 months after CT0890B infusion

  7. Minimal Residual Disease (MRD) Negativity Rate

    MRD negativity rate was assessed in participants who achieved CR, CRh, CRi or MLFS. MRD negativity was defined as <0.01% abnormal cells among CD45-positive cells as determined by multiparameter flow cytometry (MFC).

    Measured: 12 months after CT0890B infusion

  8. Pharmacokinetic Endpoint - Peak expansion (Cmax)

    The maximum concentration or peak value of CT0890B cells in plasma after infusion, measured by CAR copy number.

    Measured: 12 months after CT0890B infusion

  9. Time to peak expansion (Tmax) of CT0890B

    The time required to reach the peak expansion (maximum CAR copy number) in plasma following the infusion of CT0890B cells.

    Measured: 12 months after CT0890B infusion

  10. Area under the curve (AUC) of CT0890B

    The total cellular exposure in plasma after infusion, calculated based on the area under the CAR copy number-time curve.

    Measured: 12 months after CT0890B infusion

  11. In vivo persistence of CT0890B

    The duration for which CT0890B cells remain detectable in the plasma after infusion, monitored via CAR copy number.

    Measured: Up to 12 months after CT0890B infusion

Timeline

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

  1. First posted1 Jun 2026
  2. Study start7 May 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2029 (estimated)

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
Model description
Single Group Assignment of CAR-T
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07617285
Sponsor's protocol ID
CT0890B-CG8001
Status last verified
May 2026
First submitted
1 May 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CAR-T cells chimeric antigen receptor T cells in people with AML and Refractory/Relapse Acute Myeloid Leukemia, run by Peking University People's Hospital at 1 site 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 11 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Xiangyu Zhao, M.D,Ph.D (010-88325531, Zhao_xy@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AE) after CT0890B infusion (time frame: 12 months after CT890B infusion). 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 NCT07617285.

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 1 Jun 2026.

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