IL3 CAR-T Cell Therapy for Patients With CD123 Positive Relapsed and/or Refractory Acute Myeloid Leukemia

Launched by ZHEJIANG UNIVERSITY · Oct 21, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IL3 CAR-T cell therapy for patients with a type of blood cancer known as acute myeloid leukemia (AML) that tests positive for a marker called CD123. This therapy aims to help patients whose leukemia has come back after treatment or has not responded well to previous therapies. The trial is currently not recruiting participants, but when it starts, it will be open to adults with specific health conditions, including those who have had relapses or have not achieved complete remission after treatment.

To be eligible for the trial, participants must have a confirmed diagnosis of CD123 positive AML and meet certain health criteria, such as having a specific number of leukemia cells in their bone marrow and stable overall health. Participants can expect to undergo a new type of treatment that uses their own modified immune cells to fight the leukemia. It's important to note that individuals with certain health issues, like severe heart problems or active infections, will not be able to join the study. This trial could offer hope for patients looking for new options in fighting their leukemia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed diagnosis of CD123+ AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
• 2. Relapsed or refractory CD123+ AML (meeting one of the following conditions):
• • 1. CR not achieved after standardized chemotherapy;
• • 2. CR achieved following the first induction, but CR duration is less than 12 months;
• • 3. Ineffectively after first or multiple remedial treatments;
• • 4. 2 or more relapses;
• • 3. The number of primordial cells in bone marrow is \> 5% (by morphology), and/or \> 0.01% (by flowcytometry);
• • 4. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
• • 5. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
• • 6. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
• • 7. Estimated survival time ≥ 3 months;
• • 8. ECOG performance status 0 to 2;
• • 9. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.
• Exclusion Criteria:
• Subjects with any of the following exclusion criteria were not eligible for this trial:
• • 1. History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases;
• • 2. Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past;
• • 3. Pregnant (or lactating) women;
• • 4. Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis);
• • 5. Active infection of hepatitis B virus or hepatitis C virus;
• • 6. Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;
• • 7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
• • 8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
• • 9. Other uncontrolled diseases that were not suitable for this trial;
• • 10. Patients with HIV infection;
• • 11. Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.