Status:
TERMINATED
CAR-T Cells Therapy in Relapsed/Refractory Acute Myeloid Leukemia
Lead Sponsor:
Zhujiang Hospital
Collaborating Sponsors:
Nanfang Hospital, Southern Medical University
The Third Affiliated Hospital of Southern Medical University
Conditions:
Relapsed/Refractory Acute Myeloid Leukemia(AML)
Eligibility:
All Genders
6+ years
Phase:
NA
Brief Summary
Acute myeloid leukemia (AML) is a group of genetically highly heterogeneous malignant disease . The disease is the most common type of adult acute leukemia. Overall survival (OS) was less than 50% in ...
Detailed Description
Acute myeloid leukemia (AML) is a group of genetically highly heterogeneous malignant disease ,its' character is immature myeloid protocel abnormal differentiation and proliferation in the bone marrow...
Eligibility Criteria
Inclusion
- Relapsed/Refractory AML patients
- Positive for any of CD33, CD38, CD56, CD117, CD123, CD34, or Muc1.(cytology, genetic testing)
- Estimated survival time is more than 3 months in multiple myeloma,and Karnofsky Performance Status（KPS) score is more than 80.
- No cytapheresis and cell separation contraindication.
- Hemoglobin is more than 80 gram per litre.
- The function of important organ was satisfied:(1)cardiac ultrasound indicated that cardiac ejection fractions is more than 50%（EF≥50%）, and the electrocardiogram showed no obvious abnormality;(2)Blood oxygen saturation is more than 90%（SpO2≥90%）;(3)Creatinine（Cr） is less than 2.5 times the upper limit of normal;(4)Alanine transaminase（ALT）and glutamic-oxalacetic transaminase（AST）is less than 3 times the upper limit of normal,and total bilirubin is less than 2 milligram per deciliter(TBil≤2.0mg/dL).
- After discussion by the expert group, the patient's condition was analyzed and combined with the general physical condition of the patient, the benefit of participating in the clinical trial was greater than the risk.
- Volunteered for this clinical trail and signed a consent form .
- Currently, chemotherapy and approved targeted therapies are ineffective for the patients.Or patients cannot tolerate current chemotherapy.
Exclusion
- Active other disease and cannot control after treatment.
- Patients with actively infection of Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
- Severe psychiatric disorder or other disease in central nervous system.
- Patients are infected with fungus,bacteria or virus,and are difficult to control after treatment.
- Patients with infection of HIV .
- Pregnant or lactating women.
- Patients who have Graft-Versus-Host Disease (GVHD) should receive systemic administration of immunosuppressive agents.
- Patients have received other genetic therapy products.
- Patients who have received systemic administration of glucocorticoid agents in one week before CART therapy.
- Any situation may do harm to the subjects or interfere the results.
- Have had Prolonged QT interval or severe heart disease in the past.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03473457
Start Date
April 1 2018
End Date
December 31 2020
Last Update
September 13 2021
Active Locations (1)
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1
Southern Medical University Zhujiang Hospital
Guangdong, Guangdong, China, 510000