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Archive > Volume 26 Issue 8 > 2019,26(8):833-836. DOI:10.3872/j.issn.1007-385X.2019.08.001 Prev Next
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Several considerations on the related issues of clinical trial design of chimeric antigen receptor T lymphocytes in the treatment of lymphohematopoietic malignancies
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Abstract:
[Abstract] Chimeric antigen receptor (CAR) T lymphocyte has shown attractive prospects in the treatment of lymphohematopoietic malignancies including B-cell lymphoblastic leukemia, B-cell lymphoma and multiple myeloma. Many applicants have submitted investigational new drug (IND) applications to Center for Drug Evaluation of National Medical Products Ggency, however, many of the INDs have problems in patient selection, prognostic indicators and risk management, etc, which might hinder the evaluation of the safety and efficacy of CAR-T cells. Thus, we made some suggestions on the above-mentioned problems through summarizing clinical experience and communicating with domestic clinical experts, which the sponsors and researchers can refer to when conducting CAR-T cell clinical trials for registration.
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