CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    20
  • sponsor
    Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Updated on 4 June 2022

Summary

This is a single center, open-label ,phase 1/2 study to evaluate the safety and efficacy of targeted CD19/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Description

The patients will receive infusion of CART cells targeting CD19 and CD22 to confirm the safety and efficacy of CD19/CD22 CART Cells in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Details
Condition Leukemia, B-cell
Treatment CART-19/22
Clinical Study IdentifierNCT03614858
SponsorShanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female patients with CD19+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to <2 year). The study will enroll 20 evaluable patients as follows
Age 6-65 years
Left ventricular ejection fractions≥ 0.5 by echocardiography
Creatinine < 1.6 mg/dL
Aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal
Bilirubin <2.0 mg/dL
Karnofsky performance status ≥ 60
Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion Criteria

Pregnant or lactating women
Uncontrolled active infection
Active hepatitis B or hepatitis C infection
Class III/IV cardiovascular disability according to the New York Heart Association Classification
HIV infection
Patients with history of seizure
Active central nervous system leukemia
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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