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)

Tianjin Mycure Medical Technology Co., Ltd1 site in 1 country18 target enrollmentSeptember 7, 2018

ConditionsB-cell Acute Lymphoblastic Leukemia

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: B-cell Acute Lymphoblastic Leukemia
Sponsor: Tianjin Mycure Medical Technology Co., Ltd
Enrollment: 18
Locations: 1
Primary Endpoint: Percentage of adverse events
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This 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).

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

September 7, 2018

End Date

January 1, 2021

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tianjin Mycure Medical Technology Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

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.