Title
CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.
Phase I Study of the Safety and Efficacy of CD19 CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)
Phase
Phase 1Lead Sponsor
Tianjin Mycure Medical Technology Co., LtdStudy Type
InterventionalStatus
Unknown statusIndication/Condition
B-cell Acute Lymphoblastic LeukemiaIntervention/Treatment
CD19 CAR-T cellsStudy Participants
18This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 CD19+ B-cell relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL) patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-ALL.
T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.
Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.
Inclusion Criteria: More than 1 year; CD19 positive B-cell acute lymphoblastic leukemia; Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ECG; blood oxygen saturation ≥90%; creatinine clearance calculated by Cockcroft-Gault formula ≥40ml/min; ALT and AST≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / L. Expected to survive for more than 3 months; Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: Recent or current use of glucocorticoid or other immunosuppressor; Uncontrolled active infection, HIV infection, syphilis serology reaction positive; Has a graft-versus-host response and requires the use of immunosuppressants; Drug uncontrollable central nervous system leukemia; Pregnant or lactating female; The patient did not agree to use effective contraception during the treatment period and for the following 1 year; A history of other malignant tumors; The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.