Natural Killer(NK) Cell Therapy Targeting CLL1 or CD33 in Acute Myeloid Leukemia
ConditionAML, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University
About this trial
This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 or CD33 target Chimeric antigen receptor (CAR) -induced pluripotent stem cells derived NK cells in patients with relapsed/refractory AML
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old.
Confirmed diagnosis of r/r AML
CLL1 or CD33 expression is positive in AML blasts.
Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy greater than 12 weeks.
Disqualifiers
Allergic to drug used in this study.
History of allogeneic stem cell transplantation.
Received the vaccine within 4 weeks pror to the first infusion andor expected to reuire vaccination from the study period to 12 weeks ater the last intusion
Active central nervous system Leukemia.
Trial design
Design model
Single group
Treatments tested in this trial
iPSC-NK cells
Biological/VaccineiPSC-NK cells
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: CAR-NK cell therapy in Adult subjects with r/r AMLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability
Time frame
28 Days from first dose of iPSC NK cell infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhejiang University
Lead sponsor
Hangzhou Qihanjiyin Biotech Co.,Ltd.
Collaborator
Source ClinicalTrials.gov