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In recent years, CAR-T cells have achieved good efficacy in the treatment of many diseases of hematological tumors.
Seven products have been approved for clinical use worldwide, of which two products have been approved in China
.
In 2022, the first domestic "CAR-T Cell Therapy for Malignant Hematological Tumors and Immune Targeted Therapy-Related Infection Management Guidelines" will be published independently.
Interpretation in the Hematology Oncology Guidelines section
.
Yimaitong specially invited Professor Ying Zhitao to be interviewed to share the related issues of CAR-T cell treatment of malignant hematological tumors
.
China's CD19 CAR-T has been used in clinical practice, benefiting more patients with hematological tumors.
Last year, two commercial CAR-T products targeting CD19 were approved for marketing in China.
The number of cases of Hodgkin lymphoma is gradually increasing
.
Although some problems were encountered in the clinical application process, for example, there was a certain gap between the patients receiving treatment and the patients in the previous clinical study, and some patients did not meet the criteria for inclusion in the clinical trial, manifesting as high tumor burden, older age, comorbidities, and physical status.
Poor wait
.
However, combined with foreign real-world data and existing domestic data, it is basically similar to the clinical research results
.
Professor Ying Zhitao said that he believes that with the increase of clinical application experience of CAR-T and the accumulated experience in many clinical trials, it can help solve the problems encountered in clinical practice and benefit more patients with hematological tumors
.
China's first CAR-T guideline was released to help guide the application of CAR-T in China.
Professor Ying Zhitao said that the CAR-T guideline writing committee of the Chinese Society of Clinical Oncology has made a comprehensive summary of the progress of CAR-T therapy worldwide in recent years.
The guidelines for CAR-T cell treatment of hematological malignancies have been formulated based on the evidence of medical evidence and the principles of guideline formulation.
The introduction of this guideline is conducive to promoting the standardization, individualization and precision of CAR-T cell therapy, and guiding the more rational clinical application of CAR-T cells.
cells
.
The main contents include three parts: targeting CD19 CAR-T for B cell non-Hodgkin's lymphoma, targeting BCMA CAR-T for multiple myeloma, and targeting CD19 CAR-T for acute B lymphocytic leukemia
.
Prof.
Zhitao Ying said that the common features of the three parts put more emphasis on the whole-process management of CAR-T treatment, and each part includes multiple links
.
In the "targeted CD19 CAR-T therapy for B-cell non-Hodgkin's lymphoma" section, the indications, pre-treatment evaluation, peripheral blood mononuclear cell collection, bridging therapy, lymphocyte depletion chemotherapy, cell reinfusion, Post-transfusion monitoring, treatment of toxic and side effects, long-term follow-up and other 9 aspects (see the figure below)
.
Indications Evaluation of peripheral blood mononuclear cells before treatment Bridging therapy collection of peripheral blood mononuclear cells Lymphocyte depletion before chemotherapy Check the lymphocyte depletion chemotherapy regimen before reinfusion Confirmation of patient status before reinfusion Approaches ICANN's recommended treatment approach For multiple myeloma and acute B lymphocytic leukemia, although no corresponding CAR-T products have been approved in China, the corresponding clinical research is progressing smoothly, so BCMA-targeted CAR-T is recommended for previous recipients.
For adult patients with relapsed or refractory multiple myeloma who have received 4 or more treatments (class 2A evidence; level II expert recommendation), CD19-targeted CAR-T is recommended for relapsed/refractory acute B lymphocytic leukemia (18- 70 years) patients (Class 2A; Level II expert recommendation)
.
In addition, this guideline is more applicable to CAR-T cell products with large sample size and long-term follow-up data.
For CAR-T cells in the clinical research stage, it is recommended to refer to the corresponding clinical research manual
.
The future of CAR-T cell therapy for hematological tumors is promising.
At present, corresponding CAR-T products for the treatment of multiple myeloma and acute B lymphocytic leukemia have been approved for marketing abroad
.
The domestic registration study of CAR-T cell products for these two types of hematological tumors is nearing completion, and the corresponding products are expected to be approved for marketing in China in the near future
.
Professor Ying Zhitao said that this also confirms the timeliness of the formulation of this version of the CSCO CAR-T guidelines for the treatment of hematological malignancies
.
In addition, CAR-T with other targets in the field of hematological tumors is undergoing clinical research, and two directions are worthy of attention: First, multi-target CAR-T
.
The combination of CD19 and other targets such as CD20, CD22, etc.
forms a dual-target or triple-target CAR-T study.
Preliminary data show that dual-target CAR-T may be better than single-target CAR-T in efficacy, but it still needs to be More research data to verify
.
Second, other target CAR-Ts show good application prospects
.
For example, clinical studies of CD30-targeting CAR-T in Hodgkin lymphoma and anaplastic large cell lymphoma are in progress, and research results have been obtained abroad
.
In addition, the preliminary data of targeting CD7 CAR-T in the treatment of T-cell lymphoma or T-cell leukemia show good application prospects, which may change the current treatment status of T-cell tumors and improve the efficacy of patients, which is worth looking forward to
.
In addition, there are also ongoing studies in the field of acute myeloid leukemia, which deserve our attention
.
Expert Profile Prof.
Zhitao Ying, MD, Chief Physician, Peking University Cancer Hospital, Youth Committee Member, Hematology and Tumor Committee, China Anti-Cancer Association, Youth Committee Member, Chinese Geriatric Hematological Lymphoma Group, Chinese Medical Association Oncology Branch, Youth Committee Member, Chinese Society of Clinical Oncology (CSCO) Committee Member Member of the Professional Committee of Drug Clinical Research and Evaluation of China Elderly Health Care Association Graduated from Peking University School of Medicine in 2009 with a doctorate in oncology.
Started working in the Lymphoma Department of Peking University Cancer Hospital in 2009.
The main research direction is the standardized diagnosis and treatment of lymphoma Arrangement: Reviewed by Quinta: Professor Ying Zhitao Typesetting: Quinta Execution: Uni poke "read the original text", we will make progress together