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EX02 CAR-T Cells for Relapsed and Refractory Acute Myeloid Leukemia

ConditionsAcute Myeloid Leukemia (AML)CAR-T
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZhimin Zhai

About this trial

This is a early Phase 1 open-label, single-arm clinical study of EX02 CAR-T therapy for relapsed and refractory acute myeloid leukemia.

Each participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy of cyclophosphamide and fludarabine, and an an intravenous infusion of CAR-T cells.

Each participant will proceed through the following study procedures:

* Screening * Enrollment/Leukapheresis * Conditioning chemotherapy * CAR T treatment * Post-treatment assessment * Long-term follow-up

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

According to the Chinese Adult Acute Myeloid Leukemia (AML) Diagnosis and Treatment Guidelines (2023 edition/previous edition), patients diagnosed with acute myeloid leukemia (AML) and meeting the diagnostic criteria for refractory AML are eligible, including: initial treatment cases with no response after two courses of standard therapy; relapse within 12 months after achieving complete remission (CR) and failure of consolidation therapy; relapse after 12 months with no response to conventional chemotherapy; two or more relapses; and presence of extramedullary leukemia.

Peripheral blood, bone marrow, or extramedullary lesion specimens showing leukemia cells with positive surface expression of EX02;

ECOG performance status score of 0-2;

Age ≥18 and ≤70 years, any gender;

Disqualifiers

Active hepatitis A, B, C, HIV infection, or other severe active infections that are not yet controlled;

History of acquired immune deficiency syndrome (AIDS) or long-term use of immunosuppressants due to other diseases (including steroids, equivalent to prednisone >15mg/day);

Conditions of the heart function: a. New York Heart Association (NYHA) class III or IV heart failure; b. Myocardial infarction or coronary artery bypass surgery within the six months prior to enrollment; c. Clinically significant ventricular arrhythmia or unexplained syncope; d. History of severe non-ischemic cardiomyopathy; e. History of cardiac dysfunction (left ventricular ejection fraction <45%) within 8 weeks before enrollment;

Pregnant or lactating women; participants (both male and female) unwilling to use contraception;

Trial design

Design model

Single group

Treatments tested in this trial

  • CAR-T Cell Injection

    Biological/Vaccine

    Conditioning chemotherapy: Lymphodepletion regimen consisting of fludarabine 25 mg/m2/day and cyclophosphamide 250 mg/m2/day for 3 consecutive days, administered 48 hours before intraperitoneal infusion. On the day of administration, premedication with 500mg of acetaminophen orally and 20mg of promethazine intramuscularly or intravenously (or other non-steroidal anti-inflammatory drugs and antihistamines) should be given 30 minutes before intraperitoneal infusion. The therapeutic dose of CAR-T cells is defined as intravenous injection of 1.0E6 CAR-T cells/kg as the initial standard dosage.

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: CAR-T Cell InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment-Emergent Adverse Events (TEAE)

TEAE is defined as any adverse event that occurs within 90 days after the first injection of EX02 CAR-T, or that existed before treatment and worsened after treatment. All adverse events are graded according to CTCAE v4.0, classified, and then the incidence rate is calculated. In addition, according to the definition of this study, the occurrence of CAR-T cell therapy-specific CRS and ICANS, as well as their grading, management, and prognosis are evaluated, and the incidence rates are calculated separately, with specific patient details recorded.

Time frame
From the infusion (Day 0) to 3 months
2

Overall Response Rate (ORR)

Overall response rate=number of complete remission(CR) (including incomplete hematologic recovery (CRi)) + number of partial remission (PR) / total number of treated cases, determined by the investigator according to the 2023 Chinese Diagnosis and Treatment Guidelines for Adult Acute Myeloid Leukemia (non-acute promyelocytic leukemia).

Time frame
From the infusion (Day 0) to Day 60

Secondary outcomes

1

PFS

The time from the onset of leukocyte apheresis to the appearance of tumor progression or death

Time frame
12 months
2

OS

OS, The time between leukocyte apheresis and death from any cause

Time frame
12 months
3

ECOG scoring

Zubrod-ECOG-WHO method for assessing and comparing the physical status of patients before and after treatment

Time frame
2 months

Other outcomes

Sponsors and contacts

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

Zhimin Zhai

Lead sponsor

The Second Hospital of Anhui Medical University

Sponsor institution

Zeno Therapeutics Pte. Ltd

Collaborator

Source ClinicalTrials.gov
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