AzTrials
AzTrials

Relapsed/Refractory Acute Myeloid Leukemia(AML)Phase 1NCT07441980

A Clinical Study to Explore the Safety and Efficacy of CT1390B in Relapsed/ Refractory Acute Myeloid Leukemia

A Phase 1 study testing CAR-T cells chimeric antigen receptor T cells in people with Relapsed/Refractory Acute Myeloid Leukemia(AML), run by Institute of Hematology & Blood Diseases Hospital, China 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 CT1390B 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
18 participants
Where
1 siteChina
Study dates
2 Mar 2026to 30 Jun 2028
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 definitively diagnosed as CLL-1 positive according to the WHO 2022 classification
  • Bone marrow blast percentage ≥5% by morphology
  • Estimated survival > 12 weeks
  • ECOG score 0-2
  • Participants should meet the following test results (no ongoing supportive care)
Show all 10Show fewer
  • Left ventricular ejection fraction (LVEF) > 50%
  • ALT≤ 2.5 × ULN, AST ≤ 2.5 × ULN, total bilirubin ≤ 2 × ULN; ALT≤ 5 × ULN, AST ≤ 5 × ULN, total bilirubin ≤ 3 × ULN, if the liver is involved
  • 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

  • Participants were diagnosed with acute promyelocytic leukemia (APL) BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase), active 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 CLL-1
  • Participant has clinically significant active GVHD or is receiving systemic corticosteroids for GVHD
Show all 13Show fewer
  • 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 Lymphodepleting Chemotherapy;
  • History of uncontrolled arrhythmia of significant clinical significance (as judged by the investigator), such as ventricular arrhythmia;
  • History of severe non-ischemic cardiomyopathy;
  • Other cardiac disease that the investigator believe 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 8. Has HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis C virus infection (HCV antibody and HCV-DNA positive)

Trial locations and contacts

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

Ying Wang, Dr contact

+86-22-23909278

wangying1@ihcams.ac.cn

China1 site

  • Institute of Hematology & Blood Diseases Hospital, China

    Tianjin

Other trials in China

About this study

Official title: A Clinical Study to Investigate the Safety and Efficacy of CT1390B in Patients With Relapsed/Refractory Acute Myeloid Leukemia

A Clinical Study to Investigate the Safety and Efficacy of CT1390B 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 CT1390B in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 9~18 participants in this trial

Being tested
CAR-T cells chimeric antigen receptor T cells
Keywords
CT1390B
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.

  • CAR-T cells chimeric antigen receptor T cellsDrug

    CT1390B cells infusion

Study groups in NCT07441980
Study groupRoleWhat they receive
CT1390B CAR-T cells InjectionExperimentalCAR-T cells#chimeric antigen receptor T cells#CT1390B 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 CT1390B infusion

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

    Measured: 12 months after CT1390B infusion

  2. Dose-limiting toxicity （DLT）

    The DLT is evaluated as the proportion of patients who experienced adverse events related to CT1390B 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 CT1390B infusion

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

Secondary outcomes (11)

  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 as achieving CR,CRh and CRi

    Measured: 12 months after CT1390B 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 MLFS and PR

    Measured: 12 months after CT1390B infusion

  3. Proportion of patients undergoing stem cell transplantation following CAR-T therapy.

    Measured: 12 months after CT1390B infusion

  4. 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 CT1390B infusion

  5. 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 CT1390B infusion

  6. 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 CT1390B infusion

  7. 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 CT1390B infusion

  8. Cmax

    the peak of CARgene copy number in peripheral blood

    Measured: 28 days after CT1390B infusion

  9. Tmax

    time to reach the peak of CARgene copy number in peripheral blood

    Measured: 28 days after CT1390B infusion

  10. AUC

    area under curve of CARgene copy number in peripheral blood

    Measured: 28 days after CT1390B infusion

  11. Tlast

    duration of existence of CARgene copy number in peripheral blood

    Measured: 28 days after CT1390B infusion

Timeline

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

  1. First posted2 Mar 2026
  2. Study start2 Mar 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2028 (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
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07441980
Sponsor's protocol ID
IIT2025144
Status last verified
Feb 2026
First submitted
22 Jan 2026
Last updated
2 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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 Relapsed/Refractory Acute Myeloid Leukemia(AML), run by Institute of Hematology & Blood Diseases Hospital, China 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 10 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: opening soon, as of the sponsor's last update on 2 Mar 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 Ying Wang, Dr (+86-22-23909278, wangying1@ihcams.ac.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 CT1390B infusion (time frame: 12 months after CT1390B 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 NCT07441980.

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 2 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in