Health TrialsbyHealthPanel

Off-the-shelf CD123 CAR-NK for R/R AML

ConditionsAcute Myeloid Leukemia, in RelapseAcute Myeloid Leukemia Refractory
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • JD123 injection

    Drug

    JD123 injection is an universal Off-the-shelf CD123-targeted chimeric antigen receptor modified natural killer cells (CAR-NK) therapy derived from a healthy donor.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Experimental: Experimental: JD123 injection.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1-month DLTs

Dose limiting toxicities (DLTs)

Time frame
1-month

Secondary outcomes

1

3-month CR/CRi

Complete response (CR) or Complete remission with incomplete recovery(CRi)

Time frame
3-month
2

1-year PFS

Progression free survival(PFS)

Time frame
1-year
3

1-year OS

Overall Survival (OS)

Time frame
1-year
4

1-year MRD(-)

Proportion of subjects with minimal-residual disease (MRD) negative response

Time frame
1-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

Source ClinicalTrials.gov
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