Status:
UNKNOWN
C-CAR011 Treatment in Subjects With ALL After HSCT
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Shanghai AbelZeta Ltd.
Conditions:
Acute Lymphoblastic Leukemia(ALL)
Eligibility:
All Genders
15-65 years
Phase:
NA
Brief Summary
This is a single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT
Detailed Description
A study evaluating safety and efficacy of CBM.CD19-targeted chimeric antigen receptor T cells (C-CAR011) treatment in subjects with acute lymphoblastic leukemia(ALL) after hematopoietic stem cell tran...
Eligibility Criteria
Inclusion
- Age 15-65 years old, male or female.
- Volunteered to participate in this study and signed informed consent.
- Meet the two populations above.
- Histologically diagnosed as CD19+B-ALL.
- 100% T lymphocytes of donor.
- Treatment without chemotherapy and antibody therapy within 2 weeks prior to C-CAR011 therapy.
- Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias.
- Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection.
- Expected survival ≧ 3 months.
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
Exclusion
- History of allergy to cellular products.
- Any kind of these laboratory testing: serum total bilirubin≧2.0mg/dl, serum albumin\<35g/L, ALT, AST≧3×ULN, serum creatinine≧2.0mg/ dl,platelets\<20×109/L.
- The subjects had active aGVHD with II-IV degrees (Glucksberg degrees) or active moderate to severe cGVHD.
- Severe uncontrolled infection (mycotic, bacterial, virus and so on).
- Any central nervous system leukemia(CNS2, CNS3) , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible.
- The subjects were treated CART cells or DLI after HSCT.
- Bone marrow failure syndrome（BMF） after allogeneic hematopoietic stem cell transplantation.
- Any genetically modified T cell therapy.
- History of heavy drinking, drug taking or mental disease.
- Participated in any other clinical trial within one month prior to enrollment.
- Women who are pregnant or lactating or have breeding intent in 6 months.
- The investigators believe that any increase in the risk of the subject or interference with the results of the trial.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03327285
Start Date
March 1 2018
End Date
April 30 2021
Last Update
October 1 2020
Active Locations (1)
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1
Peking University Institute of Hematology
Beijing, Beijing Municipality, China, 100044