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

Launched by ZHIMIN ZHAI · Oct 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called EX02 CAR-T therapy for patients with a type of blood cancer known as acute myeloid leukemia (AML) that has come back or has not responded to previous treatments. The trial is currently looking for participants aged 18 to 70 who have been diagnosed with this type of leukemia and have certain conditions that qualify them for the study, such as not responding to standard therapy after two treatment cycles or having multiple relapses.

If you or a family member decide to participate, you will first go through a screening process. This involves collecting blood cells from your body, followed by a round of chemotherapy to prepare you for the CAR-T cell treatment. Once you're ready, the CAR-T cells will be infused into your bloodstream. After the treatment, there will be follow-up assessments to monitor your health over the long term. This trial is designed to gather more information about how well this new therapy works for people with difficult-to-treat AML, and participants will be closely monitored throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Peripheral blood, bone marrow, or extramedullary lesion specimens showing leukemia cells with positive surface expression of EX02;
• • 3. ECOG performance status score of 0-2;
• • 4. Age ≥18 and ≤70 years, any gender;
• • 5. 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;
• • 6. 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;
• • 7. 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 Criteria:
• • 1. Active hepatitis A, B, C, HIV infection, or other severe active infections that are not yet controlled;
• • 2. History of acquired immune deficiency syndrome (AIDS) or long-term use of immunosuppressants due to other diseases (including steroids, equivalent to prednisone \>15mg/day);
• • 3. 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;
• • 4. Pregnant or lactating women; participants (both male and female) unwilling to use contraception;
• • 5. 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);
• • 6. History of severe allergic reactions to any drugs planned for use in this study;
• • 7. 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;
• • 8. Other conditions deemed unsuitable for participation in this trial by the investigator.