Tests EX02 CAR-T cell therapy in adults with relapsed acute myeloid leukemia
Tests EX02 CAR-T cells in adults with relapsed or treatment-resistant acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: EX02 CAR-T Cells for Relapsed and Refractory Acute Myeloid Leukemia
Key facts
- Where
- Hefei, ChinaSee the site
- Phase
- Early phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 70 with acute myeloid leukemia that came back or did not respond to treatment, and whose leukemia cells carry EX02 on their surface.
- Age
- 18 to 70 years
- Sex
- Women and men can join.
- Disease stage
- Acute myeloid leukemia that did not respond to standard treatment or came back (relapsed or refractory), including leukemia outside the bone marrow. ECOG performance status of 0-2.
- Earlier treatment
- Includes people with no response after two courses of standard therapy, relapse within 12 months after complete remission with failed consolidation therapy, relapse after 12 months with no response to chemotherapy, or two or more relapses. People who had a stem cell transplant must have stopped immunosuppressants at least 6 weeks before enrolment and have no graft-versus-host disease.
- Biomarker or test result
- Leukemia cells in blood, bone marrow or other lesions must show EX02 on their surface.
Main reasons for not taking part
- Active hepatitis A, B or C, HIV infection, or other serious infection that is not under control
- History of AIDS, or long-term use of immunosuppressants such as steroids above prednisone 15mg/day
- Serious heart problems, such as NYHA class III or IV heart failure or a heart attack within the past six months
- Severe liver or kidney problems
- Pregnant or breastfeeding women, or people unwilling to use contraception
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06642025, who can take part
Where in China
- The Second Affliated Hospital of Anhui Medical UniversityHefei, ChinaContact: Zhimin ZhaiTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Zhimin Zhai
- Trial code
- NCT06642025
- Record updated
- 15 October 2024
- Original description
This is a early Phase 1 open-label, single-arm clinical study of EX02 CAR-T therapy for relapsed and refractory acute myeloid leukemia.Read full original descriptionShow less
An Open-label, Single-arm Clinical Study of EX02 CAR-T Therapy for Relapsed and Refractory Acute Myeloid Leukemia
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
Inclusion: 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; Blood cell examination meeting the following conditions: hemoglobin > 60g/L, normal T lymphocyte count (CD3+) > 0.5×10\^9/L, platelet count > 30×10\^9/L; Negative pregnancy test for women of childbearing potential before the start of the trial, and agreement to use effective contraception measures during the trial until the final follow-up; male participants of reproductive potential agreeing to use effective contraception measures during the trial until the final follow-up; Voluntary participation in this clinical study: after fully understanding the study content, voluntary signing of the informed consent form, and commitment to complete all trial procedures and activities.
Exclusion: Recipients of hematopoietic stem cell transplantation must have discontinued immunosuppressants for at least 6 weeks before enrollment and have no signs of graft-versus-host disease; 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); History of severe allergic reactions to any drugs planned for use in this study; Other conditions deemed unsuitable for participation in this trial by the investigator; 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; Severe liver or kidney dysfunction: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels exceeding 3 times the upper limit of normal, bilirubin exceeding 3 times the upper limit of normal; serum creatinine ≥ 178 μmol/L (decompensated phase); Pregnant or lactating women; participants (both male and female) unwilling to use contraception.