Study of Sequential CAR-T Cell Treating Leukemia Children

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.

Timeline

Start

2020-05-01

Primary completion

2024-05-01

Completion

2024-11-30

Outcome

Outcome not reported

Stopped: “ethic commitee decision”

Publications

• Pan J, Tang K, Luo Y, Seery S, Tan Y, Deng B, Liu F, Xu X, Ling Z, Song W, Xu J, Duan J, Wang Z, Li C, Wang K, Zhang Y, Yu X, Zheng Q, Zhao L, Zhang J, Chang AH, Feng X. Sequential CD19 and CD22 chimeric antigen receptor T-cell therapy for childhood refractory or relapsed B-cell acute lymphocytic leukaemia: a single-arm, phase 2 study. Lancet Oncol. 2023 Nov;24(11):1229-1241. doi: 10.1016/S1470-2045(23)00436-9. Epub 2023 Oct 17.

Drugs

Indications