CD123-Targeted CD16 Antibody-Modified NK Cell Immunotherapy for Refractory/Relapsed Acute Myeloid Leukemia (R/R AML)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The goal of this clinical trial is to evaluate the effectiveness of CD123-CD16 bispecific antibody-modified NK cells in treating patients with CD123-positive relapsed or refractory Acute Myeloid Leukemia (RR AML). It will also assess the safety of this modified NK cell therapy. The main questions: Does the infusion of CD123-CD16 bispecific antibody-modified NK cells induce remission in RR AML patients? What are the safety and potential adverse effects associated with the administration of these modified NK cells? Researchers will administer CD123-CD16 bispecific antibody-modified NK cells to RR AML patients and compare the outcomes to existing treatment options to determine efficacy and safety. Participants will: Undergo lymphocyte-depleting chemotherapy Fludarabine\&Cyclophosphamide from day -5 to day -3 before NK cell infusion. Receive intravenous infusions of modified NK cells at escalating doses: The first three patients will receive 1×10⁷ cells/kg. The next three patients will receive 2×10⁷ cells/kg. The final three patients will receive 4×10⁷ cells/kg. Have NK cell infusions administered every 96-120 hours for a total of three infusions, with each infusion completed within 10 to 15 minutes. Undergo dose escalation with subsequent groups only after confirming the safety of the previous dose group. Have their vital signs (temperature, heart rate, respiratory rate, blood pressure, etc.) monitored before and after each infusion. Keep baseline data records during NK cell infusions. Participate in follow-up assessments to monitor disease remission and detect any adverse events. This trial aims to provide new treatment options for RR AML patients by leveraging the targeted cytotoxic effects of CD123-CD16 bispecific antibody-modified NK cells to achieve disease remission.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age: Between18 years and 70 years.

• Diagnosis and Treatment History:

• Diagnosed with Acute Myeloid Leukemia (AML) in the hospital. Has undergone multiple first-line clinical treatments and has developed resistance to current treatments. Relapse after original induction therapy failure with a predicted survival of more than three months.

• CD123 Expression:

• Flow cytometry detection shows CD123-positive AML cells.CD123 expression level is not less than 20%.

• Hospital Examination Criteria:

• Performance Status:

• ECOG Performance Status score of 0-2 or Karnofsky Performance Status (KPS) score greater than 80.

• Donor Availability:

• Have a suitable healthy donor and agree to peripheral blood collection.

Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Chunji Gao, M.D.
gaochunji301@163.com
+86 13911536256
Backup
Yanqing Ma, M.D.
mayanqing301@163.com
+86 18201677610
Time Frame
Start Date: 2025-02-21
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 9
Treatments
Experimental: CD123-CD16 bispecific antibody-modified NK cells for the treatment of CD123-positive R/R AML
Patients scheduled to receive CD123-CD16-NK cell infusions undergo lymphocyte-depleting chemotherapy from day -5 to day -3. After completing preconditioning, 48 hours later, patients are intravenously infused with NK cells at a dose of 1×10⁷ cells/kg (100-150 ml volume) within 10 to 15 minutes. Infusions are administered every 96-120 hours for a total of three times. Subsequently, patients receive escalating NK cell doses of 2×10⁷ cells/kg and 4×10⁷ cells/kg. Vital signs (temperature, heart rate, respiratory rate, blood pressure, etc.) are monitored before and after infusion. Baseline data during NK cell infusion are also recorded. For each dose group, only one patient initially receives a single NK cell infusion, followed by a 3-day observation period to ensure safety before proceeding with a second infusion. If no adverse events occur in the initial dose group, the next dose group is infused accordingly, and the process continues similarly.
Related Therapeutic Areas
Sponsors
Leads: Chunji Gao
Collaborators: Chinese PLA General Hospital

This content was sourced from clinicaltrials.gov

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