Acute Myeloid LeukemiaPhase 1NCT07432100
Clinical Study on the Safety, Efficacy and Pharmacokinetics of Universal CLL1 Chimeric Antigen Receptor T-Cell in Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study testing universal CLL1 CAR-T cells in people with Acute Myeloid Leukemia and Chimeric Antigen Receptor T-cell, run by Mingfeng Zhao.
Trial summary
Acute myeloid leukemia (AML) is a common type of acute leukemia in adults. Although the treatment of AML has improved in recent decades, the 5-year survival rate remains below 50% due to the chemoresistance or toxicity of these treatments. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia, Chimeric Antigen Receptor T-cell, Universal CLL1 CAR-T
- What is being tested?
- universal CLL1 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to 12 Dec 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
- The patient meets the diagnostic criteria for AML as per the 2022 WHO Fifth Edition Classification of Tumours of Haematopoietic and Lymphoid Tissues (WHO-HAEM5) and the definitions of relapse and refractory AML in the "Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (2023 Edition)":Relapsed AML is defined as the reappearance of leukemia cells in the peripheral blood after achieving complete remission (CR), or the presence of more than 5% blasts in the bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or the presence of leukemia cell infiltration in extramedullary sites.Refractory AML is defined as cases that do not respond to two standard treatment courses as initial therapy; cases that relapse within 12 months after achieving CR and consolidation therapy; cases that relapse after 12 months and do not respond to conventional chemotherapy; cases with two or more relapses; and cases with persistent extramedullary leukemia.
- Diagnosis based on bone marrow and/or peripheral blood morphology within 28 days before enrollment.
- Leukemia cells express CLL1 at a level greater than 50%.
- Previous use of approved targeted drugs for relevant mutations.
- After treatment with CLL1 CAR-T, the subject must have a confirmed stem cell donor.Available for potential allo-SCT at any time.
- ECOG performance score of 0 or 1.
Show all 10Show fewer
- Adequate bone marrow reserve function: a) Absolute neutrophil count (ANC) ≥ 1000/μL, unless the investigator believes that the neutropenia is due to the underlying leukemia; b) Platelet count ≥ 50,000/μL, unless the investigator believes that the thrombocytopenia is due to the underlying leukemia; c) Absolute lymphocyte count (ALC) ≥ 100/μL.
- Adequate renal, hepatic, pulmonary and cardiac function:a) Creatinine clearance (estimated by the Cockcroft-Gault formula) ≥ 60 mL/min; b) Serum alanine aminotransferase/aspartate aminotransferase ≤ 2.5 times the upper limit of normal; c) Total bilirubin ≤ 1.5 mg/dL, except for patients with Gilbert's syndrome; d) Ejection fraction ≥ 50%, with no clinical significance in pericardial effusion as determined by echocardiogram (ECHO) and no clinical significance in electrocardiogram (ECG); e) Baseline oxygen saturation > 92%, with no clinically significant pleural effusion as determined by chest imaging.
- Contraception: Male and female patients of reproductive potential must agree to use effective contraceptive methods.
- Pregnancy test: Female patients of reproductive potential must have a negative serum or urine pregnancy test.
Who cannot join
- Patients diagnosed with acute promyelocytic leukemia.
- Patients who underwent autologous hematopoietic stem cell transplantation (SCT) within 6 weeks before enrollment.
- Patients who received donor lymphocyte infusion (DLI) within 28 days before enrollment.
- Patients with grade II-IV acute graft-versus-host disease (GVHD).
- Patients with active disease involving the central nervous system.
- Patients with a history of other malignancies except non-melanoma skin cancer or carcinoma in situ (such as cervical cancer, bladder cancer or breast cancer), who have been disease-free for at least 3 years since the last curative treatment, can be enrolled.
Show all 20Show fewer
- Patients with a history of severe hypersensitivity reactions to aminoglycoside drugs.
- Patients with genetic syndromes related to bone marrow failure.
- Patients with hereditary syndromes increase the risk of allo-SCT, such as Down syndrome (trisomy 21), which should be excluded.
- Those with a history of myocardial infarction, coronary angioplasty or stent placement, unstable angina, New York Heart Association class II or higher congestive heart failure, atrial fibrillation or other clinically significant heart diseases within 12 months prior to enrollment.
- Patients with leukemia involving the atria or ventricles.
- Those with a history of symptomatic deep vein thrombosis (DVT) or pulmonary embolism within 6 months prior to enrollment, or a history of distal upper extremity DVT within 3 months prior to conditioning.
- Patients with primary immunodeficiency diseases.
- Those with a history of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection.
- Patients with mental disorders.
- Those with existing or suspected fungal, bacterial, viral or other uncontrolled infections.
- Those who have received live vaccines within 4 weeks prior to enrollment or are expected to receive live vaccines during the study.
- Those who cannot tolerate prophylactic antifungal and antibacterial treatments.
- Those with persistent grade 2 or higher toxicity from previous treatments, excluding hematological toxicity.
- Pregnant or lactating women of childbearing age.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Acute myeloid leukemia (AML) is a common type of acute leukemia in adults. Although the treatment of AML has improved in recent decades, the 5-year survival rate remains below 50% due to the chemoresistance or toxicity of these treatments. Most patients eventually die from relapse and/or progressive disease, and these patients urgently need new treatment strategies. Chimeric antigen receptor T-cell (CAR-T cell) therapy is an adoptive immunotherapy that expresses one or more specific chimeric antigen receptors (CARs) on T cells through genetic engineering, enabling them to target tumor cells. CAR-T cell immunotherapy has been a milestone in tumor immunotherapy in recent years and has achieved remarkable efficacy in the treatment of hematological malignancies. Human C-type lectin-like molecule 1 (CLL-1) is specifically expressed on the tumor cells of more than 90% of AML patients. CLL1 is selectively expressed on the surface of leukemia stem cells but not on normal hematopoietic stem cells, making it an ideal target for AML. Autologous CLL1 CAR-T cells have shown strong therapeutic effects in previous studies. However, autologous CAR-T cells have disadvantages such as long preparation time and high cost. Universal CAR-T cells have effectively solved this problem. In this study, universal CAR-T cells targeting the CLL1 target were prepared based on the non-gene editing intracellular membrane protein retention technology, further expanding the application of CAR-T in the treatment of acute myeloid leukemia.
- Being tested
- universal CLL1 CAR-T cells
- 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.
universal CLL1 CAR-T cellsBiological
Infusion of universal CLL1 CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| Infusion of universal CLL1 CAR-T cells | Experimental | Not described Receives: Biological: universal CLL1 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone marrow tumor burden
At key time points following CAR-T cell infusion (e.g., Day 14), bone marrow samples are collected from patients via bone marrow puncture. The proportion of blast cells in the total bone marrow cells is calculated using flow cytometry to assess the therapeutic effect of CAR-T cells. A blast cell percentage of less than 5% is defined as complete remission.
Measured: Day14; Day 28；Month 3；Month 6；Month 12；Month 18；Month 24
Overall survival time
Overall survival time：Evaluate the time from CAR-T cell infusion to death or the end of follow-up for the patients.
Measured: From the date of CAR-T cell infusion to the date of death from any cause, assessed up to 60 months.
Progression-Free-Survival
Progression-free survival time: The time interval from receiving CAR-T cell infusion to disease progression or death.
Measured: From date of CAR-T cell infusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completion12 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mingfeng Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mingfeng Zhao, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432100
- Sponsor's protocol ID
- XBOP2025-11
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu J, Zhang Y, Guo R, Zhao Y, Sun R, Guo S, Lu W, Zhao M. Targeted CD7 CAR T-cells for treatment of T-Lymphocyte leukemia and lymphoma and acute myeloid leukemia: recent advances. Front Immunol. 2023 May 5;14:1170968. doi: 10.3389/fimmu.2023.1170968. eCollection 2023.
PubMed 37215124Zhao Y, Bai X, Guo S, Zhang X, Liu J, Zhao M, Xie T, Meng H, Zhang Y, He X, Zhao M. Efficacy and safety of CAR-T therapy targeting CLL1 in patients with extramedullary diseases of acute myeloid leukemia. J Transl Med. 2024 Oct 2;22(1):888. doi: 10.1186/s12967-024-05705-7.
PubMed 39358720Jin X, Zhang M, Sun R, Lyu H, Xiao X, Zhang X, Li F, Xie D, Xiong X, Wang J, Lu W, Zhang H, Zhao M. First-in-human phase I study of CLL-1 CAR-T cells in adults with relapsed/refractory acute myeloid leukemia. J Hematol Oncol. 2022 Jul 7;15(1):88. doi: 10.1186/s13045-022-01308-1.
PubMed 35799191Wagner DL, Fritsche E, Pulsipher MA, Ahmed N, Hamieh M, Hegde M, Ruella M, Savoldo B, Shah NN, Turtle CJ, Wayne AS, Abou-El-Enein M. Immunogenicity of CAR T cells in cancer therapy. Nat Rev Clin Oncol. 2021 Jun;18(6):379-393. doi: 10.1038/s41571-021-00476-2. Epub 2021 Feb 25.
PubMed 33633361Kantarjian H, Kadia T, DiNardo C, Daver N, Borthakur G, Jabbour E, Garcia-Manero G, Konopleva M, Ravandi F. Acute myeloid leukemia: current progress and future directions. Blood Cancer J. 2021 Feb 22;11(2):41. doi: 10.1038/s41408-021-00425-3.
PubMed 33619261
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety, Efficacy and Pharmacokinetics of Universal CLL1 Chimeric Antigen Receptor T-Cell in Relapsed/Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07432100
- Acronym / sponsor ID
- XBOP2025-11
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mingfeng ZhaoUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- 12 Dec 2028 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute myeloid leukemia (AML) is a common type of acute leukemia in adults. Although the treatment of AML has improved in recent decades, the 5-year survival rate remains below 50% due to the chemoresistance or toxicity of these treatments. Most patients eventually die from relapse and/or progressive disease, and these patients urgently need new treatment strategies. Chimeric antigen receptor T-cell (CAR-T cell) therapy is an adoptive immunotherapy that expresses one or more specific chimeric antigen receptors (CARs) on T cells through genetic engineering, enabling them to target tumor cells. CAR-T cell immunotherapy has been a milestone in tumor immunotherapy in recent years and has achieved remarkable efficacy in the treatment of hematological malignancies. Human C-type lectin-like molecule 1 (CLL-1) is specifically expressed on the tumor cells of more than 90% of AML patients. CLL1 is selectively expressed on the surface of leukemia stem cells but not on normal hematopoietic stem cells, making it an ideal target for AML. Autologous CLL1 CAR-T cells have shown strong therapeutic effects in previous studies. However, autologous CAR-T cells have disadvantages such as long preparation time and high cost. Universal CAR-T cells have effectively solved this problem. In this study, universal CAR-T cells targeting the CLL1 target were prepared based on the non-gene editing intracellular membrane protein retention technology, further expanding the application of CAR-T in the treatment of acute myeloid leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infusion of universal CLL1 CAR-T cells | Experimental | Biological: universal CLL1 CAR-T cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient meets the diagnostic criteria for AML as per the 2022 WHO Fifth Edition Classification of Tumours of Haematopoietic and Lymphoid Tissues (WHO-HAEM5) and the definitions of relapse and refractory AML in the "Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (2023 Edition)":Relapsed AML is defined as the reappearance of leukemia cells in the peripheral blood after achieving complete remission (CR), or the presence of more than 5% blasts in the bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or the presence of leukemia cell infiltration in extramedullary sites.Refractory AML is defined as cases that do not respond to two standard treatment courses as initial therapy; cases that relapse within 12 months after achieving CR and consolidation therapy; cases that relapse after 12 months and do not respond to conventional chemotherapy; cases with two or more relapses; and cases with persistent extramedullary leukemia.
- Diagnosis based on bone marrow and/or peripheral blood morphology within 28 days before enrollment.
- Leukemia cells express CLL1 at a level greater than 50%.
- Previous use of approved targeted drugs for relevant mutations.
- After treatment with CLL1 CAR-T, the subject must have a confirmed stem cell donor.Available for potential allo-SCT at any time.
Key exclusion criteria (20 listed)
- Patients diagnosed with acute promyelocytic leukemia.
- Patients who underwent autologous hematopoietic stem cell transplantation (SCT) within 6 weeks before enrollment.
- Patients who received donor lymphocyte infusion (DLI) within 28 days before enrollment.
- Patients with grade II-IV acute graft-versus-host disease (GVHD).
- Patients with active disease involving the central nervous system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| universal CLL1 CAR-T cellsInfusion of universal CLL1 CAR-T cells | Biological | Infusion of universal CLL1 CAR-T cells |
Primary outcome
Bone marrow tumor burden
Time frame: Day14; Day 28；Month 3；Month 6；Month 12；Month 18；Month 24
At key time points following CAR-T cell infusion (e.g., Day 14), bone marrow samples are collected from patients via bone marrow puncture. The proportion of blast cells in the total bone marrow cells is calculated using flow cytometry to assess the therapeutic effect of CAR-T cells. A blast cell percentage of less than 5% is defined as complete remission.
Overall survival time
Time frame: From the date of CAR-T cell infusion to the date of death from any cause, assessed up to 60 months.
Overall survival time：Evaluate the time from CAR-T cell infusion to death or the end of follow-up for the patients.
Progression-Free-Survival
Time frame: From date of CAR-T cell infusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60months.
Progression-free survival time: The time interval from receiving CAR-T cell infusion to disease progression or death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Results publication: PubMed 37215124Liu J, Zhang Y, Guo R, Zhao Y, Sun R, Guo S, Lu W, Zhao M. Targeted CD7 CAR T-cells for treatment of T-Lymphocyte leukemia and lymphoma and acute myeloid leukemia: recent advances. Front Immunol. 2023 May 5;14:1170968. doi: 10.3389/fimmu.2023.1170968. eCollection 2023.
- Results publication: PubMed 39358720Zhao Y, Bai X, Guo S, Zhang X, Liu J, Zhao M, Xie T, Meng H, Zhang Y, He X, Zhao M. Efficacy and safety of CAR-T therapy targeting CLL1 in patients with extramedullary diseases of acute myeloid leukemia. J Transl Med. 2024 Oct 2;22(1):888. doi: 10.1186/s12967-024-05705-7.
- Results publication: PubMed 35799191Jin X, Zhang M, Sun R, Lyu H, Xiao X, Zhang X, Li F, Xie D, Xiong X, Wang J, Lu W, Zhang H, Zhao M. First-in-human phase I study of CLL-1 CAR-T cells in adults with relapsed/refractory acute myeloid leukemia. J Hematol Oncol. 2022 Jul 7;15(1):88. doi: 10.1186/s13045-022-01308-1.
- Results publication: PubMed 33633361Wagner DL, Fritsche E, Pulsipher MA, Ahmed N, Hamieh M, Hegde M, Ruella M, Savoldo B, Shah NN, Turtle CJ, Wayne AS, Abou-El-Enein M. Immunogenicity of CAR T cells in cancer therapy. Nat Rev Clin Oncol. 2021 Jun;18(6):379-393. doi: 10.1038/s41571-021-00476-2. Epub 2021 Feb 25.
- Results publication: PubMed 33619261Kantarjian H, Kadia T, DiNardo C, Daver N, Borthakur G, Jabbour E, Garcia-Manero G, Konopleva M, Ravandi F. Acute myeloid leukemia: current progress and future directions. Blood Cancer J. 2021 Feb 22;11(2):41. doi: 10.1038/s41408-021-00425-3.
- Individual participant dataSharing planned: No
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing universal CLL1 CAR-T cells in people with Acute Myeloid Leukemia and Chimeric Antigen Receptor T-cell, run by Mingfeng Zhao.
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 20 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 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Mingfeng Zhao (+86 13752460369, mingfengzhao@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone marrow tumor burden (time frame: Day14; Day 28；Month 3；Month 6；Month 12；Month 18；Month 24). 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 NCT07432100, which also lists 5 linked publications.
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 25 Feb 2026.