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Relapsed/Refractory Acute Myeloid Leukemia(AML)Phase 1NCT07233018

A Clinical Study to Explore the Safety and Efficacy of CT0991 in Relapsed/ Refractory Acute Myeloid Leukemia

A Phase 1 study testing CT0991 CAR-T cells infusicn in people with Relapsed/Refractory Acute Myeloid Leukemia(AML), run by MEI HENG at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

A Clinical Study to Investigate the Safety and Efficacy of CT0991 in Patients with Relapsed/Refractory Acute Myeloid Leukemia. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
CT0991 CAR-T cells infusicn
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
18 Nov 2025to 30 May 2027
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Volunteer to participate in the clinical trial; Fully understand and are informed of this study and sign the informed consent form; Willing to follow and able to complete all trial procedures.
  • Age 18-75 years (inclusive), male or female.
  • Estimated survival > 12 weeks.
  • Patients with relapsed or refractory AML as defined in the Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (Version 2023);
  • Flow cytometry or immunohistochemical examination of bone marrow or peripheral blood samples showed positive expression of CD38 in tumor cells and the expression rate was ≥80%.
  • ECOG score 0-2.
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  • Participants should meet the following test results (no ongoing supportive care):
  • Left ventricular ejection fraction (LVEF) > 50%;
  • ALT≤ 2.5 × ULN, AST ≤ 2.5 × ULN, total bilirubin ≤ 2 × ULN;
  • Endogenous creatinine clearance ≥ 30 mL/min (creatinine clearance calculated using the Cockcroft-Gault formula);
  • Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN and prothrombin time (PT) ≤ 1.5 × ULN.

Who cannot join

  • The participant has any serious illness, laboratory abnormality, or psychiatric disorder that may impair the ability to receive or tolerate planned trial treatment; or the investigator judges that the participant's participation in the clinical trial is not in his/her best interest (e.g.,compromised health), or may hinder, limit, or confound protocol-specific Assessments.
  • Participants were diagnosed with acute promyelocytic leukemia (APL),BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase),secondary AML (other than MDS), 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 CD38.
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  • Participant has clinically significant active GVHD or is receiving systemic corticosteroids for GVHD.
  • 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.

HENG MEI MD,Ph.D., MD contact

027-85726114

hmei@hust.edu.cn

HENG MEI MD, MD contact

027-85726114

hmei@hust.edu.cn

China1 site

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    HENG MEI MD，Ph.D., 027-85726114, hmei@hust.edu.cn

Other trials in China

About this study

Official title: A Clinical Study to Investigate the Safety and Efficacy of CT0991 in Patients With Relapsed/Refractory Acute Myeloid Leukemia.

A Clinical Study to Investigate the Safety and Efficacy of CT0991 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 CT0991 in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 3-24 participants in this trial.

Being tested
CT0991 CAR-T cells infusicn
Keywords
CT0991
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.

  • CT0991 CAR-T cells infusicnDrug

    CAR-T cells# chimeric antigen receptor T cells#

Study groups in NCT07233018
Study groupRoleWhat they receive
CAR-T cells# chimeric antigen receptor T cells#ExperimentalCT0991 CAR-T cels inffusicn
Receives: Drug: CT0991 CAR-T cells infusicn

What is being measured

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

  1. MTD and/or dose range

    Evaluate Dose limited toxicity and recommended dosage range after CT0991 infusion.

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

  2. Adverse Events (AE) after CT0991 infusion

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

    Measured: 12 months after CT0991 infusion

  3. Dose-limiting toxicity （DLT）

    The DLT is evaluated as the proportion of patients who experienced adverse events related to CT0991 that meet the criteria for DLT events after the first infusion.

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

Secondary outcomes (7)

  1. Complete response (CR), complete response with partial hematologic recovery (CRh)

    and complete response with incomplete hematologic recovery (CRi).Performed according to the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and ELN 2022 Criteria for AML defined of Achieve CR、CRh and CRi.

    Measured: 12 months after CT0991 infusion.

  2. Morphologic leukemia-free status (MLFS) and partial response (PR)

    Performed according to the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and ELN 2022 Criteria for AML defined of Achieve CRh, MLFS and PR.

    Measured: 12 months after CT0991 infusion

  3. Duration of response （DOR)

    Participants achieving CR/CRi/CRh will be included in the analysis set for DOR. DOR is defined as the time from the date of confirmed response until the date of disease relapse or death from any cause, whichever occurs first.

    Measured: 12 months after CT0991 infusion.

  4. Event-free survival (EFS)

    Defined as the time from the date of receiving the infusion to the date of treatment failure (failure to achieve CR/CRh/CRi/MLFS/PR after both efficacy assessments), or relapse (hematologic relapse or extramedullary relapse after CR/CRh/CRi), or death from any cause, whichever occurs first. When an EFS event was "Ineffective Therapy", the primary analysis of EFS was performed on a 1-day basis (ie, time to treatment received as the event). For a more comprehensive assessment, sensitivity analyses could be performed using the actual date of treatment failure, end of treatment, or start of next-line anti-leukemia therapy as the end of EFS for treatment failure, respectively.

    Measured: 12 months after CT0991 infusion.

  5. Overall survival (OS)

    Defined as the time from the date of receiving the infusion to the date of death from any cause.

    Measured: 12 months after CT0991 infusion.

  6. Minimal Residual Disease (MRD) Negative Rate

    tested in all participants who achieved CR/CRh/CRi. MRD negativity was defined as abnormal cells detected by the MFC method accounting for < 0.1% of CD45-positive cells.

    Measured: 12 months after CT0991 infusion.

  7. Pharmacokinetic parameters of CT0991, including CAR copy number, peak value, AUC (area under the curve), in vivo persistence, etc.

    Time to peak expansion, peak expansion, area under the curve (AUC) and duration in plasma after infusion of CT0991 cells.

    Measured: 12 months after CT0991 infusion.

Timeline

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

  1. First posted18 Nov 2025
  2. Study start18 Nov 2025 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 May 2027 (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
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07233018
Sponsor's protocol ID
CT0991-CG9001_01
Status last verified
Nov 2025
First submitted
13 Nov 2025
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
Yes
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 CT0991 CAR-T cells infusicn in people with Relapsed/Refractory Acute Myeloid Leukemia(AML), run by MEI HENG 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 15 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: opening soon, as of the sponsor's last update on 18 Nov 2025. 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 HENG MEI MD,Ph.D., MD (027-85726114, hmei@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD and/or dose range (time frame: Up to 28 days after CAR-T cells 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 NCT07233018.

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 18 Nov 2025.

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