AML (Acute Myeloid Leukemia)Phase 1/2AML CAR-TNCT07370064
Clinical Study of Anti-CLL1-CD33-NKG2D Bicephali CAR-T for Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1/2 study testing CAR-T in people with AML (Acute Myeloid Leukemia), run by Xuzhou Medical University at 1 site in China.
Trial summary
This study is a clinical trial designed to evaluate the safety and efficacy of a new type of CAR-T cell therapy for patients with relapsed/refractory acute myeloid leukemia (AML). The treatment involves modifying the patient's own T cells to target and eliminate leukemia cells more effectively. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- AML (Acute Myeloid Leukemia)
- What is being tested?
- CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2026to 31 Jan 2029
- Phase
- Phase 1/2
- 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: Patients must be ≥18 years old. Diagnosis: Confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML) as per the World Health Organization (WHO) criteria.
- Prior Treatment: Must have failed at least one prior line of chemotherapy or targeted therapy.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Adequate Organ Function:
- Hematologic function: Absolute neutrophil count (ANC) ≥ 1,000/μL, platelet count ≥ 50,000/μL, and hemoglobin ≥ 8 g/dL (without transfusion support).
- Renal function: Serum creatinine ≤ 1.5 x upper limit of normal (ULN). Liver function: Total bilirubin ≤ 2 x ULN, AST/ALT ≤ 2.5 x ULN. Informed Consent: The patient must be willing and able to provide written informed consent to participate in the study.
- Eligible for Apheresis: Patients must be able to undergo the apheresis procedure to collect T cells for CAR-T cell modification.
Who cannot join
- Active Central Nervous System (CNS) Leukemia: Presence of active leukemia in the CNS.
- Pregnancy or Breastfeeding: Female patients who are pregnant or breastfeeding. Severe Active Infections: Active and uncontrolled infections, including HIV, hepatitis B or C, or any other severe systemic infections.
- Other Malignancies: History of another malignancy (except for treated, localized cancers such as basal cell carcinoma) within the past 5 years.
- Autoimmune Diseases: Active autoimmune diseases requiring systemic immunosuppressive therapy.
- History of Severe Cytokine Release Syndrome (CRS): Any history of severe CRS or neurological toxicity following prior CAR-T cell therapy.
- Allergy to Apheresis or CAR-T Cell Components: Known hypersensitivity to any of the components involved in the apheresis or CAR-T cell therapy procedure.
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- Uncontrolled Systemic Disease: Uncontrolled comorbid conditions, such as severe cardiovascular disease, uncontrolled hypertension, or severe pulmonary conditions.
- Concurrent Participation in Another Clinical Trial: Participation in another clinical trial for AML or related conditions that may interfere with this study's treatment and outcomes.
- Inability to Comply: Inability to comply with study procedures or follow-up requirements as per the investigator's judgment.
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
The Affiliated Hospital oh Xuzhou Medical University
Xuzhou, Jiangsu, 221006
Kailin Xu, PhD, 15162166166, lihmd@163.com
Qian Sun, Dr., 15949043172, sunqian3172@163.com
About this study
Official title: A Phase I/II Study to Evaluate the Safety and Efficacy of Anti-CLL1-CD33-NKG2D Bicephali CAR-T Cells in Patients With Relapsed/Refractory Acute Myeloid Leukemia
This study is a clinical trial designed to evaluate the safety and efficacy of a new type of CAR-T cell therapy for patients with relapsed/refractory acute myeloid leukemia (AML). The treatment involves modifying the patient's own T cells to target and eliminate leukemia cells more effectively. This is a cutting-edge therapy using anti-CLL1-CD33-NKG2D Bicephali CAR-T cells.
The primary goal of this study is to determine whether this treatment can improve survival and reduce the symptoms of AML in patients whose disease has not responded to standard treatments. Participants will be closely monitored for side effects and the overall effectiveness of the treatment.
Read more
Eligibility for this study includes patients who have been diagnosed with relapsed or refractory AML and have not had success with previous therapies. Participation in this study will provide access to an experimental treatment that may offer benefits beyond current treatment options, but also comes with risks.
Patients, their families, and healthcare providers will be provided with full information about the procedure, potential benefits, and risks, and they will have the opportunity to ask questions before deciding whether to participate.
Read the detailed description
This clinical trial aims to assess the safety and efficacy of a novel CAR-T cell therapy in patients with relapsed/refractory acute myeloid leukemia (AML). The treatment involves the infusion of genetically modified anti-CLL1-CD33-NKG2D Bicephali CAR-T cells, a type of immunotherapy that enhances the body's immune system to target and destroy cancerous leukemia cells. The therapy is designed to specifically target AML cells by utilizing unique markers (CLL1, CD33, and NKG2D) on the surface of the leukemia cells.
Participants in this study will undergo T cell collection, which involves harvesting their own T cells through a procedure known as apheresis. These cells will then be modified in the laboratory to express the specific CAR-T receptors. Once the cells are modified, they will be re-infused back into the patient, with the goal of activating the immune system to fight off the leukemia.
This study will closely monitor adverse effects, including any side effects of the CAR-T therapy, such as cytokine release syndrome (CRS) or neurological effects, which are known risks of CAR-T treatments. Patients will be followed for a designated period to track response rates, including the reduction of leukemia cells, progression-free survival, and overall survival.
Participants will also undergo regular health assessments, including laboratory tests, imaging studies, and routine examinations, to evaluate both the effectiveness of the treatment and potential complications.
Eligibility for this study includes adult patients with relapsed/refractory AML, meaning their disease has returned after previous treatments or has not responded to standard therapies. This trial provides an opportunity for patients who have limited treatment options to receive access to an advanced, experimental treatment that may improve their outcomes.
Patients will be fully informed about the potential risks and benefits of participating in this study, and their participation will be voluntary. Detailed informed consent will be obtained before any study-related procedures are performed.
- Conditions
- AML (Acute Myeloid Leukemia)
- Being tested
- CAR-T
- Keywords
- CAR-T
- 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-TBiological
Also called anti-CLL1-CD33-NKG2D Bicephali CAR-T cells
This arm of the study involves the administration of anti-CLL1-CD33-NKG2D Bicephali CAR-T cells to patients with relapsed/refractory acute myeloid leukemia (AML). Patients will undergo apheresis to collect their T cells, which will then be genetically modified in the laboratory to express the anti-CLL1, CD33, and NKG2D receptors. The modified CAR-T cells will be reinfused into the patient to target and eliminate AML cells. This experimental treatment aims to evaluate the safety, efficacy, and immune response associated with this novel CAR-T therapy.
Key endpoints include overall survival, progression-free survival, and response rates (such as complete remission or partial remission). Participants will be closely monitored for potential side effects, including cytokine release syndrome (CRS) and neurological toxicity, which are known risks of CAR-T cell therapy.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T | Experimental | This arm of the study involves the administration of anti-CLL1-CD33-NKG2D Bicephali CAR-T cells to patients with relapsed/refractory acute myeloid leukemia (AML). Patients will undergo apheresis to collect their T cells, which will then be genetically modified in the laboratory to express the anti-CLL1, CD33, and NKG2D receptors. The modified CAR-T cells will be reinfused into the patient to target and eliminate AML cells. This experimental treatment aims to evaluate the safety, efficacy, and immune response associated with this novel CAR-T therapy.
Key endpoints include overall survival, progression-free survival, and response rates (such as complete remission or partial remission). Participants will be closely monitored for potential side effects, including cytokine release syndrome (CRS) and neurological toxicity, which are known risks of CAR-T cell therapy. Receives: Biological: CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Complete Remission (CR) or Partial Remission (PR) in Patients with Relapsed/Refractory AML Following CAR-T Therapy
The primary outcome measure is the rate of complete remission (CR) or partial remission (PR) in patients with relapsed or refractory acute myeloid leukemia (AML) following the administration of anti-CLL1-CD33-NKG2D Bicephali CAR-T cells. CR and PR will be defined according to standard hematologic criteria, including complete resolution or reduction of leukemia cell counts and improvement in bone marrow function. This measure will be assessed using bone marrow biopsies and flow cytometry
Measured: The primary outcome will be assessed at 3 months post-treatment for each participant, with additional follow-up assessments at 6 months and 12 months to monitor remission status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start31 Jan 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML (Acute Myeloid Leukemia)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is designed as an interventional clinical trial to evaluate the safety and efficacy of anti-CLL1-CD33-NKG2D Bicephali CAR-T cells in patients with relapsed/refractory acute myeloid leukemia (AML). The study will be conducted in a single-arm design, where all participants will receive the experimental treatment. There will be no comparison group or placebo arm. Participants in the study will undergo apheresis, a procedure to collect their T cells, which will then be genetically modified to express the anti-CLL1-CD33-NKG2D receptors. After the modification process, these CAR-T cells will be infused back into the patient to target and eliminate AML cells. This trial will assess the following key components: Safety and Efficacy.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Responsible party
- Principal investigator, Kai Lin Xu，MD, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370064
- Sponsor's protocol ID
- XYFY2025-KL517-01
- Other IDs
- XYFY2025-KL517-01
- Acronym
- AML CAR-T
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality and Privacy Concerns: The data collected in this study contains sensitive health information about participants. Protecting patient confidentiality and privacy is of utmost importance, and sharing IPD might pose risks to privacy protections. Regulatory Compliance: As the study involves the use of experimental treatments (CAR-T therapy), the sharing of IPD must adhere to strict regulatory guidelines and agreements that protect the intellectual property and ensure the appropriate handling of such data. Ongoing Data Analysis: The data from this study is still being analyzed for key outcomes. Sharing incomplete or early-stage data could lead to misinterpretation of the results, affecting the scientific integrity of the study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate the Safety and Efficacy of Anti-CLL1-CD33-NKG2D Bicephali CAR-T Cells in Patients With Relapsed/Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07370064
- Acronym / sponsor ID
- AML CAR-T / XYFY2025-KL517-01
- Conditions
- AML (Acute Myeloid Leukemia)
- Keywords
- CAR-T
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 27 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 is a clinical trial designed to evaluate the safety and efficacy of a new type of CAR-T cell therapy for patients with relapsed/refractory acute myeloid leukemia (AML). The treatment involves modifying the patient's own T cells to target and eliminate leukemia cells more effectively. This is a cutting-edge therapy using anti-CLL1-CD33-NKG2D Bicephali CAR-T cells.
The primary goal of this study is to determine whether this treatment can improve survival and reduce the symptoms of AML in patients whose disease has not responded to standard treatments. Participants will be closely monitored for side effects and the overall effectiveness of the treatment.
Eligibility for this study includes patients who have been diagnosed with relapsed or refractory AML and have not had success with previous therapies. Participation in this study will provide access to an experimental treatment that may offer benefits beyond current treatment options, but also comes with risks.
Patients, their families, and healthcare providers will be provided with full information about the procedure, potential benefits, and risks, and they will have the opportunity to ask questions before deciding whether to participate.
Detailed description
This clinical trial aims to assess the safety and efficacy of a novel CAR-T cell therapy in patients with relapsed/refractory acute myeloid leukemia (AML). The treatment involves the infusion of genetically modified anti-CLL1-CD33-NKG2D Bicephali CAR-T cells, a type of immunotherapy that enhances the body's immune system to target and destroy cancerous leukemia cells. The therapy is designed to specifically target AML cells by utilizing unique markers (CLL1, CD33, and NKG2D) on the surface of the leukemia cells.
Participants in this study will undergo T cell collection, which involves harvesting their own T cells through a procedure known as apheresis. These cells will then be modified in the laboratory to express the specific CAR-T receptors. Once the cells are modified, they will be re-infused back into the patient, with the goal of activating the immune system to fight off the leukemia.
This study will closely monitor adverse effects, including any side effects of the CAR-T therapy, such as cytokine release syndrome (CRS) or neurological effects, which are known risks of CAR-T treatments. Patients will be followed for a designated period to track response rates, including the reduction of leukemia cells, progression-free survival, and overall survival.
Participants will also undergo regular health assessments, including laboratory tests, imaging studies, and routine examinations, to evaluate both the effectiveness of the treatment and potential complications.
Eligibility for this study includes adult patients with relapsed/refractory AML, meaning their disease has returned after previous treatments or has not responded to standard therapies. This trial provides an opportunity for patients who have limited treatment options to receive access to an advanced, experimental treatment that may improve their outcomes.
Patients will be fully informed about the potential risks and benefits of participating in this study, and their participation will be voluntary. Detailed informed consent will be obtained before any study-related procedures are performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is designed as an interventional clinical trial to evaluate the safety and efficacy of anti-CLL1-CD33-NKG2D Bicephali CAR-T cells in patients with relapsed/refractory acute myeloid leukemia (AML). The study will be conducted in a single-arm design, where all participants will receive the experimental treatment. There will be no comparison group or placebo arm. Participants in the study will undergo apheresis, a procedure to collect their T cells, which will then be genetically modified to express the anti-CLL1-CD33-NKG2D receptors. After the modification process, these CAR-T cells will be infused back into the patient to target and eliminate AML cells. This trial will assess the following key components: Safety and Efficacy.
| Arm | Type | Receives |
|---|---|---|
| CAR-T | Experimental | Biological: CAR-TThis arm of the study involves the administration of anti-CLL1-CD33-NKG2D Bicephali CAR-T cells to patients with relapsed/refractory acute myeloid leukemia (AML). Patients will undergo apheresis to collect their T cells, which will then be genetically modified in the laboratory to express the anti-CLL1, CD33, and NKG2D receptors. The modified CAR-T cells will be reinfused into the patient to target and eliminate AML cells. This experimental treatment aims to evaluate the safety, efficacy, and immune response associated with this novel CAR-T therapy. Key endpoints include overall survival, progression-free survival, and response rates (such as complete remission or partial remission). Participants will be closely monitored for potential side effects, including cytokine release syndrome (CRS) and neurological toxicity, which are known risks of CAR-T cell therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: Patients must be ≥18 years old. Diagnosis: Confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML) as per the World Health Organization (WHO) criteria.
- Prior Treatment: Must have failed at least one prior line of chemotherapy or targeted therapy.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Hematologic function: Absolute neutrophil count (ANC) ≥ 1,000/μL, platelet count ≥ 50,000/μL, and hemoglobin ≥ 8 g/dL (without transfusion support).
- Renal function: Serum creatinine ≤ 1.5 x upper limit of normal (ULN). Liver function: Total bilirubin ≤ 2 x ULN, AST/ALT ≤ 2.5 x ULN. Informed Consent: The patient must be willing and able to provide written informed consent to participate in the study.
Key exclusion criteria (9 listed)
- Active Central Nervous System (CNS) Leukemia: Presence of active leukemia in the CNS.
- Pregnancy or Breastfeeding: Female patients who are pregnant or breastfeeding. Severe Active Infections: Active and uncontrolled infections, including HIV, hepatitis B or C, or any other severe systemic infections.
- Other Malignancies: History of another malignancy (except for treated, localized cancers such as basal cell carcinoma) within the past 5 years.
- Autoimmune Diseases: Active autoimmune diseases requiring systemic immunosuppressive therapy.
- History of Severe Cytokine Release Syndrome (CRS): Any history of severe CRS or neurological toxicity following prior CAR-T cell therapy.
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 |
|---|---|---|
| CAR-TAlso: anti-CLL1-CD33-NKG2D Bicephali CAR-T cellsThis arm of the study involves the administration of anti-CLL1-CD33-NKG2D Bicephali CAR-T cells to patients with relapsed/refractory acute myeloid leukemia (AML). Patients will undergo apheresis to collect their T cells, which will then be genetically modified in the laboratory to express the anti-CLL1, CD33, and NKG2D receptors. The modified CAR-T cells will be reinfused into the patient to target and eliminate AML cells. This experimental treatment aims to evaluate the safety, efficacy, and immune response associated with this novel CAR-T therapy. Key endpoints include overall survival, progression-free survival, and response rates (such as complete remission or partial remission). Participants will be closely monitored for potential side effects, including cytokine release syndrome (CRS) and neurological toxicity, which are known risks of CAR-T cell therapy. | Biological | CAR-T |
Primary outcome
Rate of Complete Remission (CR) or Partial Remission (PR) in Patients with Relapsed/Refractory AML Following CAR-T Therapy
Time frame: The primary outcome will be assessed at 3 months post-treatment for each participant, with additional follow-up assessments at 6 months and 12 months to monitor remission status
The primary outcome measure is the rate of complete remission (CR) or partial remission (PR) in patients with relapsed or refractory acute myeloid leukemia (AML) following the administration of anti-CLL1-CD33-NKG2D Bicephali CAR-T cells. CR and PR will be defined according to standard hematologic criteria, including complete resolution or reduction of leukemia cell counts and improvement in bone marrow function. This measure will be assessed using bone marrow biopsies and flow cytometry
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 27 Jan 2026.
- Individual participant dataSharing planned: No. Confidentiality and Privacy Concerns: The data collected in this study contains sensitive health information about participants. Protecting patient confidentiality and privacy is of utmost importance, and sharing IPD might pose risks to privacy protections. Regulatory Compliance: As the study involves the use of experimental treatments (CAR-T therapy), the sharing of IPD must adhere to strict regulatory guidelines and agreements that protect the intellectual property and ensure the appropriate handling of such data. Ongoing Data Analysis: The data from this study is still being analyzed for key outcomes. Sharing incomplete or early-stage data could lead to misinterpretation of the results, affecting the scientific integrity of the study.
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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 Phase 1/2 study testing CAR-T in people with AML (Acute Myeloid Leukemia), run by Xuzhou Medical University 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 7 inclusion and 9 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 27 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Kailin Xu, PhD (15162166166, lihmd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Complete Remission (CR) or Partial Remission (PR) in Patients with Relapsed/Refractory AML Following CAR-T Therapy (time frame: The primary outcome will be assessed at 3 months post-treatment for each participant, with additional follow-up assessments at 6 months and 12 months to monitor remission status). 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 27 Jan 2026.