CAR-T Cell Therapy Targeting to CD19 for R/R ALL

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    50
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 3 February 2022

Summary

Refractory and relapsed (R/R) acute lymphoblastic leukemia (ALL) patients with active disease always have a dismal outcome. Chimeric antigen receptor (CAR) T-cell therapy targeting to Cluster of Differentiation Antigen 19 (CD19) has been proved as a potent approach to attain remission in B-cell R/R patients. Therefore, the investigators conduct a trial to evaluate the the efficacy and safety of locally producing CAR T cells targeting CD19, and to analyze the outcome of enrolled B-cell ALL patients with active disease or persistent residual disease.

Details
Condition Acute Lymphoblastic Leukemia With Failed Remission
Treatment CAR T-cell therapy
Clinical Study IdentifierNCT03919240
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on3 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosed as CD19+ B-cell acute lymphoblastic leukemia
Fail to achieve remission, or with persistent residual disease after at least 2 cycles of consolidation
With an estimated survival of higher than 3 months (according to investigator's judgement)
Sufficient organ function: left ventricular ejection fractions 0.5 by echocardiography, creatinine < 1.6 mg/dL, aspartate aminotransferase/aspartate aminotransferase < 3 x upper limit of normal, bilirubin <2.0 mg/dL
Karnofsky performance status 60 or ECOG 2

Exclusion Criteria

Intolerant to immunosuppressive chemotherapies
With active infection or other uncontrolled complications
With history of seizure
Active hepatitis B or hepatitis C infection and HIV infection
Pregnant or lactating women, or patients refusing to take effective contraception measures
Other contraindications that considered inappropriate to participate in this trial (according to investigator's judgement)
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