EX02 CAR-T Cells for Relapsed and Refractory Acute Myeloid Leukemia
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
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
Treatments tested in this trial
- CAR-T Cell Injection
Treatment groups
9 Participants
are divided into 1 treatment groupSponsors and collaborators
Zhimin Zhai
Lead sponsor
The Second Hospital of Anhui Medical University
Sponsor institution
Zeno Therapeutics Pte. Ltd
Collaborator
Source ClinicalTrials.gov