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Spots Global Cancer Trial Database for Study of Sequential CAR-T Cell Treating Leukemia Children

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Trial Identification

Brief Title: Study of Sequential CAR-T Cell Treating Leukemia Children

Official Title: Phase II Study of Sequential Chimeric Antigen Receptor T Cell Targeting at Different B-cell Antigens Treating Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia Children

Study ID: NCT04340154

Study Description

Brief Summary: The investigators will conduct a phase II clinical trial of sequential chimeric antigen receptor T cell targeting at different B-cell antigens in refractory or relapsed B-cell acute lymphoblastic leukemia children in Beijing Boren Hospital. The study will be approved by the institutional review board of Beijing Boren Hospital, and informed consent will be obtained in accordance with the Declaration of Helsinki. All these participants will be matched the diagnostic criteria for (r/r) B-ALL according to the WHO classification and complete morphological evaluation, immunophenotype analysis by flow cytometry (FCM), cytogenetic analysis by routine G-banding karyotype analysis and leukemia fusion gene screening by multiplex nested reverse transcriptase-polymerase chain reaction (PCR). Participants will be eligible if they are heavily treated B-ALL who failed from re-induction chemotherapy after relapse or continued MRD+ for more than three months, and had positive CD19 and CD22 expressions on leukemia blasts by FCM (\>95% CD19 and \>95% CD22). After CAR T-cell infusion, clinical outcomes including overall survival (OS), disease-free survival (DFS), adverse effects and relapse will be evaluated.

Detailed Description:

Keywords

Eligibility

Minimum Age: 0 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Beijing Boren Hospital, Beijing, Beijing, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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