CAR-T cell therapy for acute myeloid leukemia that returned or resisted treatment
Tests CAR-T cells in adults with relapsed or treatment-resistant acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Clinical Study of Anti-CLL1-CD33-NKG2D Bicephali CAR-T for Relapsed/Refractory Acute Myeloid Leukemia
Key facts
- Where
- Xuzhou, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with acute myeloid leukemia (AML) that has come back or has not responded to earlier treatment. It tests a CAR-T cell therapy made from the patient's own T cells.
- Age
- 18 to 70 years
- Sex
- Women and men can join.
- Disease stage
- Acute myeloid leukemia (AML) that has relapsed or has not responded to treatment (relapsed or refractory), confirmed by WHO criteria.
- Earlier treatment
- At least one earlier line of chemotherapy or targeted therapy that did not work.
Main reasons for not taking part
- Active leukemia in the central nervous system (CNS)
- Pregnant or breastfeeding
- Uncontrolled infections, including HIV, hepatitis B or C
- Another cancer in the past 5 years (except treated, localized cancers such as basal cell carcinoma)
- Severe CRS or neurological toxicity after earlier CAR-T therapy
Read by machine on 13 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07370064, who can take part
Where in China
- The Affiliated Hospital oh Xuzhou Medical UniversityXuzhou, ChinaContact: Kailin Xu, PhDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Xuzhou Medical University
- Trial code
- NCT07370064
- Record updated
- 27 January 2026
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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.
Exclusion: History of Severe Cytokine Release Syndrome (CRS): Any history of severe CRS or neurological toxicity following prior CAR-T cell therapy; 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; 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; 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; Uncontrolled Systemic Disease: Uncontrolled comorbid conditions, such as severe cardiovascular disease, uncontrolled hypertension, or severe pulmonary conditions; Active Central Nervous System (CNS) Leukemia: Presence of active leukemia in the CNS; Inability to Comply: Inability to comply with study procedures or follow-up requirements as per the investigator's judgment.