Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL

  • STATUS
    Recruiting
  • End date
    Jan 31, 2025
  • participants needed
    50
  • sponsor
    Zhejiang University
Updated on 12 February 2021

Summary

Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia

Description

This is a prospective, single arm study. To evaluate the safety and efficacy of sequential CD19 and CD22 CAR-T cells in the treatment of adult newly diagnosed Ph chromosome negative B-cell acute lymphoblastic leukemia. The main endpoints were dose limiting toxicity (DLT) and incidence of adverse events (TEAEs).

Details
Condition B-Cell Acute Lymphoblastic Leukemia, Adult
Treatment CAR-T cells targeting CD19 and CD22
Clinical Study IdentifierNCT04740203
SponsorZhejiang University
Last Modified on12 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age15 years old
Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification
The immunophenotype of leukemia cells were CD19 and CD22 positive
Ph- or Ph- like negative
Anticipated survival time more than 12 weeks
Those who voluntarily participated in this trial and provided informed consent

Exclusion Criteria

History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases
Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past
Pregnant (or lactating) women
Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis)
Active infection of hepatitis B virus or hepatitis C virus
Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids
Previously treated with any CAR-T cell product or other genetically-modified T cell therapies
Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl
Other uncontrolled diseases that were not suitable for this trial
Patients with HIV infection
Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
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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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