Off-the-shelf CD123 CAR-NK for R/R AML
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital
About this trial
This is a single-centre, single-arm, open-label, first-in-human (FIH) study to evaluate the safety, tolerability and preliminary efficacy of universal Off-the-shelf CAR-NK cells targeted CD123 (JD123 injection) in the treatment of refractory or relapsed CD123-positive acute myeloid leukemia (AML).
Eligibility criteria
Qualifiers
Age ≥ 18 years old, no gender or race;
Expected survival period ≥ 3 months;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
Disqualifiers
Active Central nervous system leukemia;
Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide;
Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids);
Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.
Trial design
Treatments tested in this trial
- JD123 injection
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov