Clinical Study of Anti-CLL1-CD33-NKG2D Bicephali CAR-T for Relapsed/Refractory Acute Myeloid Leukemia

NCT07370064 | Not Yet Recruiting Phase 1

• 1 other identifier: XYFY2025-KL517-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

AML (Acute Myeloid Leukemia)

Keywords

CAR-T

Outcome Measures

Primary Outcomes (1)

• 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

  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

Study Arms (1)

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.

Biological: CAR-T

Interventions

CAR-T BIOLOGICAL

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.

Also known as: anti-CLL1-CD33-NKG2D Bicephali CAR-T cells

CAR-T

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Xuzhou Medical University: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

The Affiliated Hospital oh Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Kailin Xu, PhD

CONTACT

15162166166; lihmd@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 27, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)