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A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

ConditionsAcute Myeloid Leukemia (AML)CAR-T Cell Therapy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 to 75 years old at the time of signing the Informed Consent Form (ICF)

More than 12 weeks of expected survival

ECOG score 0 or 1

Relapsed or refractory AML

Disqualifiers

Acute Promyelocytic Leukemia (APL)

Mixed Phenotype Acute Leukemia (MPAL)

Acute Undifferentiated Leukemia (AUL)

Only extramedullary leukemia

Trial design

Design model

Single group

Treatments tested in this trial

  • A-CAR028

    Biological/Vaccine

    A-CAR028 is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD33 and CLL-1 antigens

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: A-CAR028Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of dose limiting toxicities (DLTs)

Time frame
Throughout the 28 days post A-CAR028 infusion
2

Incidence and severity of Treatment Emergent Adverse Events (TEAEs)

Time frame
Throughout the 3 months post A-CAR028 infusion

Secondary outcomes

1

Incidence and severity of Adverse Events (AEs)

Time frame
Throughout the 2 years post A-CAR028 infusion
2

Overall Response Rate (ORR): including Complete Response (CR), CR with Partial Hematologic Recovery (CRh), CR with Incomplete Hematologic Recovery (CRi), Morphologic Leukemia-free State (MLFS) and Partial Response (PR)

Time frame
Throughout the 2 years post A-CAR028 infusion
3

Duration of Response (DOR)

Time frame
Throughout the 2 years post A-CAR028 infusion
4

Event-free Survival (EFS)

Time frame
Throughout the 2 years post A-CAR028 infusion

Other outcomes

Sponsors and contacts

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

First Affiliated Hospital of Zhejiang University

Lead sponsor

Shanghai AbelZeta Ltd.

Collaborator

Source ClinicalTrials.gov
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