Actively Recruiting
EX02 CAR-T Cells for Relapsed and Refractory Acute Myeloid Leukemia
Led by Zhimin Zhai · Updated on 2024-10-15
9
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
Z
Zhimin Zhai
Lead Sponsor
Z
Zeno Therapeutics Pte. Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
EX02 CAR-T Cells for Relapsed and Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with acute myeloid leukemia (AML) that is refractory or relapsed according to Chinese Adult AML Guidelines
- Leukemia cells with positive EX02 surface expression in blood, bone marrow, or extramedullary lesions
- ECOG performance status score of 0 to 2
- Age between 18 and 70 years, any gender
- Hemoglobin above 60 g/L, T lymphocyte count (CD3+) above 0.5x10^9/L, platelet count above 30x10^9/L
- Negative pregnancy test for women of childbearing potential before trial start and agreement to use effective contraception during the study
- Male participants agreeing to use effective contraception during the study
- Voluntary signing of informed consent and commitment to complete all trial procedures
You will not qualify if you...
- Active hepatitis A, B, or C, HIV infection, or other severe uncontrolled infections
- History of AIDS or long-term use of immunosuppressants including steroids above prednisone 15 mg/day
- Heart conditions including NYHA class III or IV heart failure, recent myocardial infarction or bypass surgery, significant arrhythmia or unexplained syncope, severe non-ischemic cardiomyopathy, or cardiac dysfunction with ejection fraction below 45%
- Pregnant or lactating women or participants unwilling to use contraception
- Severe liver or kidney dysfunction with elevated liver enzymes or high serum creatinine
- History of severe allergic reactions to drugs planned for this study
- Hematopoietic stem cell transplant recipients must be off immunosuppressants for at least 6 weeks and have no graft-versus-host disease
- Any other condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230031
Actively Recruiting
Research Team
Z
Zhimin Zhai, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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