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

  • STATUS
    Recruiting
  • End date
    Mar 5, 2025
  • participants needed
    50
  • sponsor
    Zhejiang University
Updated on 15 March 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 Positive 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 positive 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, B-Cell Acute Lymphoblastic Leukemia, Adult
Treatment CAR-T cells targeting CD19 and CD22
Clinical Study IdentifierNCT04788472
SponsorZhejiang University
Last Modified on15 March 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; Phor 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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