AMLNCT07342244
Safety and Efficacy of CLL1 CAR-T Followed by Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
A study testing CLL1 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell Transplantation in people with AML and AML (Acute Myeloid Leukemia), run by Donghua Zhang at 1 site in China.
Trial summary
This study aims to evaluate whether an innovative combination therapy (CLL1 CAR-T sequential allogeneic hematopoietic stem cell transplantation) is safe, feasible and effective for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML). Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- AML, AML (Acute Myeloid Leukemia)
- What is being tested?
- CLL1 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2026to 20 Dec 2029
- Phase
- Interventional
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients or their guardians understand and voluntarily sign the informed consent form, and are expected to complete the follow-up examinations and treatments as required by the study protocol.
- Age between 18-75 years (inclusive), gender not restricted. Confirmed diagnosis of acute myeloid leukemia (AML), with prior receipt of at least one course of systemic chemotherapy, and efficacy assessment showing relapse/refractory disease.
- Flow cytometry of bone marrow examination or immunohistochemistry of tumor pathology at screening confirms positive expression of CLL1 target.
- Patients have recovered from the toxicity of previous treatments, i.e., CTCAE toxicity grade < 2 (unless the abnormality is tumor-related or judged by the investigator to be in a stable state with little impact on safety or efficacy).
- ECOG performance status score 0-2 and expected survival time > 3 months. Adequate organ function:a) Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)b) Aspartate aminotransferase (AST) ≤ 3 × ULNc) Total bilirubin ≤ 1.5 × ULNd) Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/mine) Hemoglobin ≥ 60 g/L or maintained at this level after blood transfusionf) Indoor oxygen saturation ≥ 92%g) Left ventricular ejection fraction (LVEF) ≥ 45% Capable of establishing venous access required for apheresis, with no contraindications to leukapheresis.
Who cannot join
- History of other malignancies within 3 years prior to screening, except for adequately treated cervical carcinoma in situ, papillary thyroid carcinoma, basal cell or squamous cell skin carcinoma, locally treated prostate cancer after radical treatment, and ductal carcinoma in situ after radical treatment.
- Diagnosis of Waldenström macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis at screening.
- Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with HBV DNA titer in peripheral blood above the lower limit of detection of the research institution; positive for hepatitis C virus (HCV) antibody with positive HCV-RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; cytomegalovirus (CMV) DNA quantitative test above the lower limit of detection of the research institution; positive for Treponema pallidum antibody; Epstein-Barr virus (EBV) DNA quantitative test above the lower limit of detection of the research institution.
- History of severe allergic reactions [severe allergic reaction is defined as grade 2 or higher allergic reaction, with any of the following clinical manifestations: airway obstruction (runny nose, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest] or known hypersensitivity to any active ingredients, excipients of the study drugs (including lymphodepletion regimen), murine products, or heterologous proteins.
- History of severe cardiac disease, including but not limited to severe arrhythmia, unstable angina, large myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, myocardial infarction or coronary artery bypass grafting (CABG) within ≤ 6 months prior to screening, history of unexplained syncope not due to vasovagal reaction or dehydration, history of severe non-ischemic cardiomyopathy, refractory hypertension (refractory hypertension is defined as: despite lifestyle modifications, blood pressure remains uncontrolled after >1 month of treatment with ≥3 antihypertensive drugs (including diuretics) at reasonable and tolerable maximum doses, or requires ≥4 antihypertensive drugs to effectively control blood pressure).
- Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring medical treatment.
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- Previous organ transplantation or planned organ transplantation (except hematopoietic stem cell transplantation).
- Previous receipt of CAR-T therapy. History of acute/chronic graft-versus-host disease (GVHD) within 6 months prior to screening, or patients requiring immunosuppressive therapy for GVHD.
- Active autoimmune or inflammatory neurological diseases (e.g., Guillain-Barré syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)).
- Presence of tumor emergencies (e.g., spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome, etc.) requiring urgent treatment at screening or before infusion.
- Uncontrolled bacterial, fungal, viral or other infections requiring antibiotic treatment.
- Use of short-acting hematopoietic cytokines affecting blood counts within 1 week prior to planned blood collection for CAR-T manufacturing, or use of long-acting hematopoietic cytokines within 2 weeks prior to screening, and judged by the investigator to have an impact on cell manufacturing.
- Receipt of corticosteroids or immunosuppressive drugs within 2 weeks prior to planned blood collection for CAR-T manufacturing at screening, and judged by the investigator to have an impact on cell manufacturing:a) Corticosteroids: Subjects receiving systemic steroid therapy within 2 weeks prior to planned blood collection for CAR-T manufacturing at screening and judged by the investigator to require long-term systemic steroid therapy during treatment (except inhaled or topical use); and subjects receiving systemic steroid therapy within 72 hours before cell infusion (except inhaled or topical use).b) Immunosuppressants: Subjects receiving immunosuppressive therapy within 2 weeks prior to planned blood collection for CAR-T manufacturing at screening.
- Major surgical procedures (except diagnostic surgery and biopsy) within 4 weeks prior to lymphodepletion or planned major surgery during the study period, or surgical wounds not fully healed before enrollment.
- Vaccination with (attenuated) live viral vaccines within 4 weeks prior to screening.
- Presence of severe mental illness. History of alcoholism or drug abuse. Pregnant or lactating women, and female subjects planning pregnancy within 2 years after cell infusion or male subjects whose partners plan pregnancy within 2 years after their cell infusion.
- Subjects with contraindications to any study procedures or other medical conditions that may expose them to unacceptable risks, as judged by the investigator and/or according to clinical standards.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 448000
Andie Fu, 15926614832, andie_fu@163.com
About this study
This study aims to evaluate whether an innovative combination therapy (CLL1 CAR-T sequential allogeneic hematopoietic stem cell transplantation) is safe, feasible and effective for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML).
- Conditions
- AML, AML (Acute Myeloid Leukemia)
- Being tested
- CLL1 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell Transplantation
- 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 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell TransplantationDrug
CLL1 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell Transplantation
| Study group | Role | What they receive |
|---|---|---|
| Experimental:Experimental group | Experimental | CLL1 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell Transplantation Receives: Drug: CLL1 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 1,3,6,12,18,24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completion20 Dec 2028 (estimated)
- Study completion20 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Donghua Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Donghua Zhang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342244
- Sponsor's protocol ID
- DHZ1962-D
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of CLL1 CAR-T Followed by Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07342244
- Acronym / sponsor ID
- DHZ1962-D
- Conditions
- AML, AML (Acute Myeloid Leukemia)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Donghua ZhangUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 20 Dec 2028 (estimated)
- Study completion
- 20 Dec 2029 (estimated)
- First posted
- 15 Jan 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.
This study aims to evaluate whether an innovative combination therapy (CLL1 CAR-T sequential allogeneic hematopoietic stem cell transplantation) is safe, feasible and effective for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental:Experimental group | Experimental | Drug: CLL1 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell TransplantationCLL1 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell Transplantation |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients or their guardians understand and voluntarily sign the informed consent form, and are expected to complete the follow-up examinations and treatments as required by the study protocol.
- Age between 18-75 years (inclusive), gender not restricted. Confirmed diagnosis of acute myeloid leukemia (AML), with prior receipt of at least one course of systemic chemotherapy, and efficacy assessment showing relapse/refractory disease.
- Flow cytometry of bone marrow examination or immunohistochemistry of tumor pathology at screening confirms positive expression of CLL1 target.
- Patients have recovered from the toxicity of previous treatments, i.e., CTCAE toxicity grade < 2 (unless the abnormality is tumor-related or judged by the investigator to be in a stable state with little impact on safety or efficacy).
- ECOG performance status score 0-2 and expected survival time > 3 months. Adequate organ function:a) Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)b) Aspartate aminotransferase (AST) ≤ 3 × ULNc) Total bilirubin ≤ 1.5 × ULNd) Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/mine) Hemoglobin ≥ 60 g/L or maintained at this level after blood transfusionf) Indoor oxygen saturation ≥ 92%g) Left ventricular ejection fraction (LVEF) ≥ 45% Capable of establishing venous access required for apheresis, with no contraindications to leukapheresis.
Key exclusion criteria (17 listed)
- History of other malignancies within 3 years prior to screening, except for adequately treated cervical carcinoma in situ, papillary thyroid carcinoma, basal cell or squamous cell skin carcinoma, locally treated prostate cancer after radical treatment, and ductal carcinoma in situ after radical treatment.
- Diagnosis of Waldenström macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis at screening.
- Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with HBV DNA titer in peripheral blood above the lower limit of detection of the research institution; positive for hepatitis C virus (HCV) antibody with positive HCV-RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; cytomegalovirus (CMV) DNA quantitative test above the lower limit of detection of the research institution; positive for Treponema pallidum antibody; Epstein-Barr virus (EBV) DNA quantitative test above the lower limit of detection of the research institution.
- History of severe allergic reactions [severe allergic reaction is defined as grade 2 or higher allergic reaction, with any of the following clinical manifestations: airway obstruction (runny nose, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest] or known hypersensitivity to any active ingredients, excipients of the study drugs (including lymphodepletion regimen), murine products, or heterologous proteins.
- History of severe cardiac disease, including but not limited to severe arrhythmia, unstable angina, large myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, myocardial infarction or coronary artery bypass grafting (CABG) within ≤ 6 months prior to screening, history of unexplained syncope not due to vasovagal reaction or dehydration, history of severe non-ischemic cardiomyopathy, refractory hypertension (refractory hypertension is defined as: despite lifestyle modifications, blood pressure remains uncontrolled after >1 month of treatment with ≥3 antihypertensive drugs (including diuretics) at reasonable and tolerable maximum doses, or requires ≥4 antihypertensive drugs to effectively control blood pressure).
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 |
|---|---|---|
| CLL1 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell TransplantationCLL1 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell Transplantation | Drug | Experimental:Experimental group |
Primary outcome
Overall survival
Time frame: 1,3,6,12,18,24 months after treatment
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 15 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLL1 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell Transplantation in people with AML and AML (Acute Myeloid Leukemia), run by Donghua Zhang 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 5 inclusion and 17 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 15 Jan 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.
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 Andie Fu Fu (15926614832, andie_fu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1,3,6,12,18,24 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2026.