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Acute Myeloid LeukemiaPhase 1NCT06880354

A Clinical Study to Evaluate the Safety and Efficacy of CLL1 and CD38 Dual-Target CAR-T Cell Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1 study testing CLL1 and CD38 Dual-Target CAR-T Cell Injection in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China 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
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Trial summary

This is a single-arm, open-label, phase I dose-escalation clinical study to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual-target CAR T cell injection in r/r AML subjects. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
CLL1 and CD38 Dual-Target CAR-T Cell Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteChina
Study dates
22 May 2025to 31 Mar 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

  • At the time of signing the informed consent, 18-70 years old (including the critical value);
  • Diagnosed with acute myeloid leukemia (except for APL) based on the World Health Organization (WHO) 2022 criteria and meeting the diagnostic criteria for relapsed/refractory AML (refer to the 2023 Chinese Guidelines for the Diagnosis and Treatment of relapsed refractory acute myeloid leukemia);
  • Positive expression of CLL1 and/or CD38 in tumor cells;
  • Estimated survival ≥3 months;
  • Have a confirmed donor for allogeneic hematopoietic stem cell transplantation. After the CAR-T cells were infused, subjects could undergo potential allogeneic hematopoietic stem cell transplantation at any time;
  • ECOG score of 0~2 during the screening phase;
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  • Adequate functional reserve of organs:
  • Alanine aminotransferase/aspartate aminotransferase ≤2.5× ULN;
  • Total serum bilirubin ≤2× ULN, except in subjects with congenital bilirubinemia (direct bilirubin ≤1.5× ULN in subjects with Gilbert's syndrome);
  • Serum creatinine clearance > 45mL/min (calculated according to Cockcroft-Gault formula);
  • Left ventricular ejection fraction (LVEF) ≥45%;
  • Basal finger oxygen saturation ≥92% in room air.
  • The ability to discontinue corticosteroids (dexamethasone ≥3mg/ day or other equivalent dose of hormones) from day 7 and continue until 30 days after CAR T cell infusion;
  • Pregnant women of childbearing potential should be negative for HCG (immunofluorescence) tests during screening and baseline. Male subjects must agree not to donate sperm for at least two years after the infusion. Male subjects and his sexual partner with childbearing potential must agree to use highly effective contraception for at least 2 years after the infusion;
  • Agree to follow-up in accordance with the protocol and the requirements outlined in the informed consent form;
  • Voluntarily sign the ICF.

Who cannot join

  • Known allergy to any of the drug ingredients to be used in this study;
  • With a history of the following concomitant treatments:
  • Received a cumulative dose of prednisone (or equivalent corticosteroids). Greater than or equal to ≥ 70 mg within 7 days prior to apheresis;
  • Based on the investigator's assessment, there is a comorbidity that requires the use of systemic corticosteroids (≥ 70 mg total dose of prednisone or equivalent doses of other corticosteroids) or other immunosuppressive medications within 12 weeks after the study treatment;
  • Received systemic anti-tumor therapy within 14 days before apheresis or within five half-lives of the drug, whichever was shorter, including but not limited to cytotoxic therapy, targeted therapy, or an investigational drug treatment;
  • Received radiotherapy 4 weeks before apheresis;
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  • Received donor lymphocyte infusion within 6 weeks before apheresis.
  • Acute promyelocytic leukemia was diagnosed;
  • Have previously been received CAR-T therapy, CAR-NK therapy or any other genetically modified cell therapy;
  • Received allogeneic hematopoietic stem cell transplantation within 6 months before screening phase;
  • Active graft-versus-host disease (GvHD) at the time of screening or active acute or chronic GvHD within 4 weeks of enrollment or the need for immunosuppressive drugs;
  • An active infection that requires systemic treatment;
  • Any history of active malignancy (excluding non-melanoma skin cancer, cervical carcinoma in situ, bladder cancer, breast cancer, or other similar cancers, with a disease-free survival period of more than 5 years and no signs of recurrence after curative treatment);
  • Experienced a stroke or seizure within 6 months prior to signing the ICF;
  • Presence of any heart diseases as follows:
  • New York Heart Association (NYHA) Stage III or IV heart failure;
  • Myocardial infarction or coronary artery bypass graft (CABG) ≤ 6 months prior to enrollment;
  • Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, degree II-III atrioventricular block, and electrocardiographic corrected QTcF interval ≥480 ms;
  • History of severe non-ischemic cardiomyopathy;
  • Cardiac dysfunction (LV <45%), as assessed by echocardiography or multigated acquisition scanning, or other clinically symptomatic cardiac disease within 6 months before enrollment;
  • Clinically uncontrolled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100mmHg) (based on the mean of ≥2 measurements).
  • Active or past central nervous system involvement, or clinical manifestations of central involvement in acute myeloid leukemia;
  • Any positive results of the following virological test results:
  • Human immunodeficiency virus antibodies (HIV antibodies);
  • Hepatitis B surface antigen (HBsAg) positive; Or hepatitis B core antibody (HBcAb) positive, and hepatitis B virus (HBV) -DNA copy number higher than the lower limit of detection;
  • Hepatitis C virus antibody positive, and hepatitis C virus RNA higher than the lower limit of detection;
  • Treponema pallidum antibody (TPPA antibody).
  • There is pulmonary fibrosis;
  • With active autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, etc.);
  • Received live attenuated vaccine within 4 weeks prior to screening;
  • Receipt of major surgery within 4 weeks prior to apheresis or a plan to receive surgeries during the study (except for diagnostic biopsy);
  • Pregnant women or nursing women who do not agree to give up breastfeeding, men and women who plan to have children during the study period or within 2 years after receiving the study treatment;
  • Acute side effects caused by previous treatment did not return to grade 1 or below (except those that the investigators judged to have no safety risk, such as hair loss, stable hypothyroidism after hormone replacement therapy, etc.);
  • According to the investigator's judgment, conditions that interfere with the subject's participation in the entire trial, confound the trial results, or make participation in the trial not in the best interest of the subject.

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 contact

022-23909095

wangying1@ihcams.ac.cn

China1 site, 1 recruiting

  • Institute of Hematology & Blood Diseases Hospital, China

    Tianjin

    Ying Wang, 022-23909095, wangying1@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

This is a single-arm, open-label, phase I dose-escalation clinical study to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual-target CAR T cell injection in r/r AML subjects.

Read the detailed description

This is a single-arm, open-label, phase I dose-escalation clinical study to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual-target CAR T cell injection in r/r AML subjects.

The main purpose of this study is to evaluate the safety of CLL1 and CD38 dual - target CAR - T cell injection in the treatment of r/r AML and the study contains two phases with the first phase adopting an ATD design and the second phase adopting a 3+3 design.

Being tested
CLL1 and CD38 Dual-Target CAR-T Cell Injection
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.

  • CLL1 and CD38 Dual-Target CAR-T Cell InjectionDrug

    This product is a lentiviral gene-modified autologous chimeric antigen receptor T-cell product that targets both CLL1 and CD38.

Study groups in NCT06880354
Study groupRoleWhat they receive
Intervention（CLL1 and CD38 Dual-Target CAR-T Cell Injection）ExperimentalThis study is a single-center open-label clinical study. The main purpose is an IIT clinical trial to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual CAR-T injection in r/r AML subjects . The enrolled subjects were patients with relapsed and refractory acute myeloid leukemia (r/r AML) .
Receives: Drug: CLL1 and CD38 Dual-Target CAR-T Cell Injection

What is being measured

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

  1. Dose-Limiting Toxicity (DLT) Rate

    Proportion of subjects with DLT within 28 days after infusion of CLL1/CD38 dual-target CAR-T cell injection.

    Measured: 28 days

  2. Adverse Events （AEs）

    Proportion of subjects experiencing AE within 96 weeks after infusion of CLL1/CD38 dual-target CAR-T cell injection.

    Measured: 96 weeks

Secondary outcomes (8)

  1. Complete Remission Rate (CRc)

    Proportion of subjects achieving CR + CR with partial hematologic recovery (CRh) +CR with incomplete hematologic recovery (CRi) (Patients achieving CRh are no longer repeatedly recorded as CRi).

    Measured: 96 weeks

  2. Overall Response Rate (ORR)

    Proportion of subjects achieving CR+CRi+CRh+MLFS+PR.

    Measured: 96 weeks

  3. MRD negative rate and MRD negative duration

    MRD negative proportion and MRD negative duration in CR/CRh/CRi subjects were measured by qPCR and/or flow cytometry.

    Measured: 96 weeks

  4. Duration of Remission（DOR）

    The time from CR/CRh/CRi first assessed to disease recurrence or death from any cause.

    Measured: 96 weeks

  5. Event-free Survival (EFS)

    The time from receiving CAR-T cell infusion to treatment failure, disease relapse, or death from any cause (whichever occurs first).

    Measured: 96 weeks

  6. Overall Survival (OS)

    The time from cell infusion to death from any cause was calculated.

    Measured: 96 weeks

  7. Indicators of proliferation and survival in vivo

    The number of CAR gene copies and CAR-T cells in bone marrow and peripheral blood after receiving CAR-T cell infusion.

    Measured: 96 weeks

  8. Anti-drug Antibodies

    Proportion of subjects who developed anti-drug antibodies in peripheral blood after CAR-T cell injection infusion.

    Measured: 96 weeks

Timeline

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

  1. First posted17 Mar 2025
  2. Study start22 May 2025
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 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
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06880354
Sponsor's protocol ID
IIT2024059
Status last verified
Jan 2025
First submitted
11 Mar 2025
Last updated
3 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CLL1 and CD38 Dual-Target CAR-T Cell Injection in people with Acute Myeloid Leukemia, 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 16 inclusion and 34 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 3 Jun 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 Ying Wang (022-23909095, wangying1@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) Rate (time frame: 28 days). The study lists 2 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 NCT06880354.

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 3 Jun 2025.

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