Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)

Launched by XUZHOU MEDICAL UNIVERSITY · Nov 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called anti Tim-3/CD123 CAR-T cell therapy for patients with relapsed or refractory acute myeloid leukemia (AML), which means their leukemia has come back or has not responded to previous treatments. The main goal of this trial is to see how safe and effective this therapy is for patients. It is currently recruiting participants aged 18 to 70 who have been diagnosed with this type of leukemia and have recovered from any side effects of earlier treatments. Participants should also have good overall health, as determined by specific medical tests.

If you or a loved one are considering joining the study, you should know that you will need to sign a consent form to participate. While in the trial, you will receive the CAR-T cell therapy, and doctors will closely monitor your health to ensure safety. There are certain health conditions that might prevent someone from participating, such as serious heart issues or active infections. Overall, this trial offers a potential new option for patients with difficult-to-treat leukemia, and it aims to improve outcomes for those affected by this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;
• • 2. At the age of 18-70 years old;
• • 3. Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);
• • 4. The patient has recovered from the toxicity of previous treatment;
• • 5. ECOG score ≤ 2 and expected survival period is not less than 3 months;
• • 6. Adequate organ function defined as:AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL/min; Hemoglobin ≥60g/L ; Indoor oxygen saturation ≥92%; LVEF≥45%;
• • 7. Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;
• • 8. From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception.
• Exclusion Criteria:
• • 1. Diagnosis of acute promyelocytic leukemia;
• • 2. History or presence of a CNS disorder;
• • 3. HBsAg is positive; HCV #HIV or Syphilis antibody are positive, CMV-DNA in peripheral blood is more than≥500 copies /mL;
• • 4. History of severe hypersensitivity reaction;
• • 5. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment;
• • 6. History of organ transplant surgery;
• • 7. Required systemic application of immunosuppressive or other drugs;
• • 8. Auto-SCT within the 3 months before enrollment;
• • 9. Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES));
• • 10. Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TLS)) ;
• • 11. Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management;
• • 12. Live vaccine received within the ≤ 4 weeks before enrollment;
• • 13. Persons with serious mental illness;
• • 14. History of major surgical operations four weeks before enrollment;
• • 15. History of alcoholism or substance abuse;
• • 16. Was identified by the investigators as unsuitable to participate in the study.