CD123-CD16-NK Cells Immunotherapy for AML
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChunji Gao
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age: Between18 years and 70 years.
Have a suitable healthy donor and agree to peripheral blood collection.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Donor-derived CD123-CD16 bispecific antibody-modified NK cells
DrugPatients enrolled sequentially received varying doses of NK cell infusions. The first three patients received 1×10⁷ cells/kg, the next three received 2×10⁷ cells/kg, and the final three received 4×10⁷ cells/kg.
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: CD123-CD16 bispecific antibody-modified NK cells for the treatment of CD123-positive R/R AMLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR
Overall Response Rate
Time frame
Bone marrow aspiration assessments are conducted one week after each patient's treatment completion, followed by evaluations at 1 month, 3 months, and 6 months.2
CR
Complete Remission Rate
Time frame
Bone marrow aspiration assessments are conducted one week after each patient's treatment completion, followed by evaluations at 1 month, 3 months, and 6 months.3
AE
Adverse events related to cell reinfusion (≥ Grade 3 treatment-related organ toxicity, laboratory tests, and Grade 4 hematologic toxicity, etc.) and number of participants with treatment-related AEs assessed by CTCAE v5.0
Time frame
14 days-28 days after infusionSecondary outcomes
1
Progressive Disease (PD)
PD parameters: content of CD123+AML cells in peripheral blood ; plasma cytokine levels at various time points;
Time frame
14 days-28 days after infusion2
Stable Disease (SD)
the condition without significant progression nor significant reduction in AML cells after treatment. The disease is stable, with no significant change in the number of leukemia cells in peripheral blood or bone marrow assessed by IRC.
Time frame
14 days-28 days after infusion3
Progression-free survival (PFS)
the time from cell last infusion to the first assessment of tumor progression, relapse, or death for any reason
Time frame
through study completion, an average of 6-12moths4
Overall survival (OS)
the time from cell last infusion to death for any reason
Time frame
through study completion, an average of 6-12mothsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chunji Gao
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
Chinese PLA General Hospital
Collaborator
Source ClinicalTrials.gov