Status:
UNKNOWN
Safety and Efficacy of CD123-Targeted CAR-T Therapy for Relapsed/Refractory Acute Myeloid Leukemia
Lead Sponsor:
Chongqing Precision Biotech Co., Ltd
Conditions:
Leukemia
Leukemia, Myeloid
Eligibility:
All Genders
3-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a single arm study to evaluate the efficacy and safety of CD123-targeted CAR-T cells therapy for patients with relapsed/refractory Acute Myeloid Leukemia.
Detailed Description
There are limited options for treatment of relapse/refractory Acute Myeloid Leukemia. CD123 is expressed on most myeloid leukemia cells so it is an ideal target for CAR-T. Some researches have reveale...
Eligibility Criteria
Inclusion
- Signed written informed consent;
- Diagnose as relapsed /refractory acute myeloid leukemia, and meet one of the following conditions:
- Failed to standard chemotherapy regimens;
- Relapse after complete remission, high-risk and / or refractory patients ;
- Relapse after hematopoietic stem cell transplantation;
- Evidence for cell membrane CD123 expression;
- All genders, ages: 3 to 75 years；
- The expect time of survive is above 12 weeks;
- KPS\>60；
- No serious mental disorders ;
- Left ventricular ejection fraction ≥50%
- Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
- Sufficient renal function defined by creatinine clearance≤2 x ULN;
- Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
- With single or venous blood collection standards, and no other cell collection contraindications;
- Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Exclusion
- Have received CAR-T therapy or other genetically modified cell therapy before screening；
- Participated in other clinical research within 1 month before screening；
- Have received the following anti-tumor treatment before screening: Have received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except those who have confirmed disease progression after treatment;
- Live attenuated vaccine within 4 weeks before screening;
- Convulsion or stoke within past 6 months;
- Previous history of other malignancy;
- Presence of uncontrolled active infection;
- Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA titer is higher than the lower limit of detection of the research institution; HIV antibody positive; syphilis primary screening antibody positive;
- Pregnant or breasting-feeding women;
- Any situation that investigators regard not suitable for attending in this study or may affect the data analysis.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04272125
Start Date
December 1 2019
End Date
July 1 2024
Last Update
April 18 2023
Active Locations (1)
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1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China