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 1
  • Study Type

  • Status

    Unknown status
  • Study Participants

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).
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.
Study Started
Sep 07
Primary Completion
Jan 01
Study Completion
Jan 01
Last Update
Sep 14

Biological CD19 CAR-T cells

T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.

CD19-CAR-T Cells Experimental

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.
No Results Posted