Lymphoid Hematological Malignancies Clinical Trial
Official title:
A Study of CD20/CD22 Targeted CAR T-cell Therapy for Relapsed or Refractory Lymphoid Malignancies
A Study of CD20/CD22 Targeted CAR T-cell Therapy for Relapsed or Refractory Lymphoid Malignancies.
Relapsed/refractory hematological malignancies has a short survival time and a high mortality
rate. A number of clinical trials in China and at abroad have shown that CAR T-cells
targeting CD19 have a high remission rate and limited adverse effects in the treatment of
relapsed/refractory leukemia, which has great clinical application prospect. The New England
Journal (NEJM) reported in 2010 and 2013 that the Carl June's team at the University of
Pennsylvania used CAR T-cells against CD19 to treat B-cell malignancies successfully. On
August 30, 2017, the US FDA first approved Novartis CAR T-cells for the treatment of acute
lymphocytic leukemia. Our center has completed the treatment of 33 cases of acute
lymphoblastic leukemia with CAR-T cells targeting CD19, with a complete remission rate of 90%
and 10 cases of lymphoma treated with CAR T-cells. At present, the international clinical
trials of CD20 / CD22 dual-target CAR T-cells in the treatment of relapsed/refractory
lymphoid hematological malignancies have achieved impressive results, but the number of
patients needs to be further verified.
Based on the results of prior studies and the lack of effective treatment options for
relapsed/refractory hematological malignancies, we have applied for a clinical trial of CD20
/ CD22 dual-target CAR T-cells to treat relapsed/refractory hematological malignancy.
This is a single arm, open-label, single-center study. Patients with CD20 and CD22-positive
relapsed/refractory hematological malignancies have an estimated survival of 2 years. The
purpose is to evaluate the safety and effectiveness of CD20 / CD22 dual-target CAR T-cell
therapy through this clinical trial study, and to provide clinical basis and experience for
CAR T-cell technology in the treatment of clinical malignant hematological diseases.
;
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|---|---|---|---|
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Phase 1/Phase 2 | |
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