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In recent years, chimeric antigen receptor T cell (CAR-T) therapy has received extensive attention in the field of hematological tumors due to its excellent efficacy
.
The CAR-T product of WuXi Genuo for the treatment of relapsed and refractory large B-cell lymphoma, Ruiji Oranxai injection, will soon be launched in China
.
Yimaitong is honored to invite Professor Song Yuqin, deputy director of the Lymphoma Department of Peking University Cancer Hospital, to share his research results and clinical experience on the standardized management of the entire process of CAR-T treatment
.
Prof.
Song Yuqin, Deputy Director, Chief Physician, and Doctoral Supervisor, Lymphoma Department, Peking University Cancer Hospital, Director, Chinese Society of Clinical Oncology (CSCO), Secretary-General, Chinese Society of Clinical Oncology (CSCO) Anti-Lymphoma Alliance, Chairman, Beijing Anti-Cancer Association, Lymphhaematological Oncology Committee Vice Chairman of Lymphoma Professional Committee of Chinese Society of Geriatric Oncology, Vice Chairman of Lymphoma Professional Committee of Chinese Geriatric Health Association, Member and Secretary of Beijing Medical Association Oncology Professional Committee Yi Maitong: CAR-T clinical application requires full-process standardized management to ensure safety And efficacy
.
Would you please briefly introduce what links are included in CAR-T's entire process management? Which ones need to be mainly involved and controlled by lymphoma specialists? Professor Song Yuqin, our department has been carrying out CAR-T treatment since 2013.
The most used CAR-T product of WuXi Junuo is mainly used for the treatment of relapsed and refractory large B-cell lymphoma
.
There are several important links in the whole process management of CAR-T
.
The first is patient screening.
Our goal is to find patients who have all aspects of physical fitness and are suitable for CAR-T treatment
.
Secondly, leukocyte apheresis is also very important.
It is necessary to collect enough and good quality leukocytes for the preparation of CAR-T cells
.
Third, during the preparation of CAR-T cells, clinicians must also pay attention to whether patients can safely wait for CAR-T cell reinfusion
.
If the patient's disease progresses rapidly and the tumor burden is high, bridging therapy may be needed to reduce the tumor burden and delay the disease progression
.
After the preparation of CAR-T cells is completed, the patient will be treated for lymphatic cleaning.
At present, the FC regimen (fludarabine + cyclophosphamide) is mainly used for lymphoma treatment
.
Fourth, the safety of the CAR-T cell reinfusion process is also very important
.
After reinfusion, it is necessary to closely observe the patient's adverse events, including cytokine release syndrome (CRS) and neurotoxicity (NT)
.
The last step is for the patient to enter the follow-up observation stage.
Since CAR-T cells are active and persist in the human body, monitoring the activity of CAR-T cells can understand tumor remission, so long-term follow-up is required
.
I think that as a lymphoma doctor, it is very important to pay close attention to all aspects of the whole process management of CAR-T treatment
.
Yimaitong: When selecting patients, which patients are suitable for CAR-T treatment? What factors can help predict efficacy and patient prognosis? Professor Song Yuqin can consider from several aspects about which patients are suitable for CAR-T treatment
.
The first is the indications.
At present, the indications approved for CAR-T therapy in China are mainly used for relapsed and refractory large B-cell lymphoma after second-line treatment or autologous hematopoietic stem cell transplantation
.
But for some special types of lymphoma, as long as CD19 is positive, you can also try to use it when there is no better choice, so that the patient can get the best treatment.
.
The second is the general condition of patients.
Patients with better ECOG scores are suitable for CAR-T treatment
.
If the patient's general condition is poor, severe CRS or neurotoxicity may occur after reinfusion, this should also be noted
.
The third is the age of the patient.
In clinical trials, there is no clear upper limit for age.
However, according to global data, elderly patients may have a higher risk of adverse events during treatment
.
In addition, tumors involve cavities, especially gastrointestinal lymphomas with transmural invasion.
If CAR-T treatment is very effective, the lesions will be relieved quickly
.
However, gastrointestinal perforation and bleeding may occur in the process of remission.
Therefore, it is necessary to be cautious in the application process and pay close attention to these adverse events.
Once they occur, they must cooperate closely with the critical rescue ward or surgery, so as to bring the benefits to the patient.
The best benefit
.
At present, there are no clear indicators that can predict the efficacy of CAR-T and the prognosis of patients
.
For CAR-T targeting CD19, CD19-positive patients may have a certain therapeutic effect
.
We can use some strategies to improve the efficacy.
For patients who have received strong immunosuppressive therapy or high-intensity chemotherapy, the number of T lymphocytes may be sufficient, but the quality and activity may not be high
.
If the condition permits, patients can be allowed to rest properly, and CAR-T treatment can be performed after the activity and function of T lymphocytes have been restored to a certain extent, which may improve the efficacy
.
There are also some studies that have found that if the CAR-T cell expansion in the body is not satisfactory after the patient's infusion of CAR-T cells, other methods can be used for intervention, such as combination medication, which can stimulate the expansion of CAR-T cells in the body.
, Helps to improve curative effect
.
Yimaitong: In clinical practice, how to monitor and manage patients' adverse reactions after CAR-T cell infusion? Professor Song Yuqin's CAR-T treatment-related adverse events can be divided into two categories
.
One type is clearing-out treatment, that is, related adverse events caused by fludarabine + cyclophosphamide treatment
.
Patients may have bone marrow suppression, such as leukopenia, anemia, and thrombocytopenia, and symptomatic and supportive treatment can be performed
.
The other is the adverse events after CAR-T cell reinfusion, mainly CRS and neurotoxicity, which require special attention in the clinic
.
For such adverse reactions, many centers are very experienced.
If a patient develops CRS or neurotoxicity, tocilizumab and glucocorticoids should be used, and both have routine treatment procedures
.
Our department also has very practical diagnosis and treatment standards.
It is very important for every young doctor, whether it is a graduate student or a first-line doctor, to learn this process first
.
Of course, cytokines must be closely monitored during treatment to guide clinical treatment
.
If the patient's adverse event is more serious, it is necessary to communicate with the intensive care unit in time and deal with it in a timely manner, so that the patient can safely pass the reaction period of the adverse event, and finally obtain a good effect
.
Yimaitong: Could you please talk about the future industry standard for CAR-T full-process management? Professor Song Yuqin Professor Song Yuqin: In the future, CAR-T whole-process management practices should start with patient screening, and planning should even begin at the previous stage of screening
.
Because the preliminary treatment is very important for the subsequent success of CAR-T treatment, or to improve the efficacy of CAR-T
.
In addition, for patients, what is the most suitable bridging treatment, the treatment of adverse events after CAR-T cell reinfusion, and there may even be some differences in the treatment of different CAR-T products.
We must pay attention to it.
.
In addition, long-term follow-up is also very important
.
Some patients in our department started treatment in 2013 and continue to remission now, with the longest follow-up time of more than five or six years
.
We need to pay attention to many issues, such as whether CAR-T cells continue to expand in the patient's body, whether the expansion is under control, and whether the patient's condition is stable
.
In addition, some patients still have fertility needs and are even worried about whether a second tumor will occur
.
The whole process of CAR-T management is 15-17 years in accordance with the requirements of clinical trials, which is a long-term follow-up process
.
In the future, more and more CAR-T products will be on the market, and more and more patients will be treated with CAR-T, which may require 15-20 years of long-term follow-up
.
I think it is necessary to establish a registration center or reporting system to carry out long-term follow-up of patients to control the trends and safety of CAR-T treatment at any time
.
Poke "read the original text", we make progress together
.
The CAR-T product of WuXi Genuo for the treatment of relapsed and refractory large B-cell lymphoma, Ruiji Oranxai injection, will soon be launched in China
.
Yimaitong is honored to invite Professor Song Yuqin, deputy director of the Lymphoma Department of Peking University Cancer Hospital, to share his research results and clinical experience on the standardized management of the entire process of CAR-T treatment
.
Prof.
Song Yuqin, Deputy Director, Chief Physician, and Doctoral Supervisor, Lymphoma Department, Peking University Cancer Hospital, Director, Chinese Society of Clinical Oncology (CSCO), Secretary-General, Chinese Society of Clinical Oncology (CSCO) Anti-Lymphoma Alliance, Chairman, Beijing Anti-Cancer Association, Lymphhaematological Oncology Committee Vice Chairman of Lymphoma Professional Committee of Chinese Society of Geriatric Oncology, Vice Chairman of Lymphoma Professional Committee of Chinese Geriatric Health Association, Member and Secretary of Beijing Medical Association Oncology Professional Committee Yi Maitong: CAR-T clinical application requires full-process standardized management to ensure safety And efficacy
.
Would you please briefly introduce what links are included in CAR-T's entire process management? Which ones need to be mainly involved and controlled by lymphoma specialists? Professor Song Yuqin, our department has been carrying out CAR-T treatment since 2013.
The most used CAR-T product of WuXi Junuo is mainly used for the treatment of relapsed and refractory large B-cell lymphoma
.
There are several important links in the whole process management of CAR-T
.
The first is patient screening.
Our goal is to find patients who have all aspects of physical fitness and are suitable for CAR-T treatment
.
Secondly, leukocyte apheresis is also very important.
It is necessary to collect enough and good quality leukocytes for the preparation of CAR-T cells
.
Third, during the preparation of CAR-T cells, clinicians must also pay attention to whether patients can safely wait for CAR-T cell reinfusion
.
If the patient's disease progresses rapidly and the tumor burden is high, bridging therapy may be needed to reduce the tumor burden and delay the disease progression
.
After the preparation of CAR-T cells is completed, the patient will be treated for lymphatic cleaning.
At present, the FC regimen (fludarabine + cyclophosphamide) is mainly used for lymphoma treatment
.
Fourth, the safety of the CAR-T cell reinfusion process is also very important
.
After reinfusion, it is necessary to closely observe the patient's adverse events, including cytokine release syndrome (CRS) and neurotoxicity (NT)
.
The last step is for the patient to enter the follow-up observation stage.
Since CAR-T cells are active and persist in the human body, monitoring the activity of CAR-T cells can understand tumor remission, so long-term follow-up is required
.
I think that as a lymphoma doctor, it is very important to pay close attention to all aspects of the whole process management of CAR-T treatment
.
Yimaitong: When selecting patients, which patients are suitable for CAR-T treatment? What factors can help predict efficacy and patient prognosis? Professor Song Yuqin can consider from several aspects about which patients are suitable for CAR-T treatment
.
The first is the indications.
At present, the indications approved for CAR-T therapy in China are mainly used for relapsed and refractory large B-cell lymphoma after second-line treatment or autologous hematopoietic stem cell transplantation
.
But for some special types of lymphoma, as long as CD19 is positive, you can also try to use it when there is no better choice, so that the patient can get the best treatment.
.
The second is the general condition of patients.
Patients with better ECOG scores are suitable for CAR-T treatment
.
If the patient's general condition is poor, severe CRS or neurotoxicity may occur after reinfusion, this should also be noted
.
The third is the age of the patient.
In clinical trials, there is no clear upper limit for age.
However, according to global data, elderly patients may have a higher risk of adverse events during treatment
.
In addition, tumors involve cavities, especially gastrointestinal lymphomas with transmural invasion.
If CAR-T treatment is very effective, the lesions will be relieved quickly
.
However, gastrointestinal perforation and bleeding may occur in the process of remission.
Therefore, it is necessary to be cautious in the application process and pay close attention to these adverse events.
Once they occur, they must cooperate closely with the critical rescue ward or surgery, so as to bring the benefits to the patient.
The best benefit
.
At present, there are no clear indicators that can predict the efficacy of CAR-T and the prognosis of patients
.
For CAR-T targeting CD19, CD19-positive patients may have a certain therapeutic effect
.
We can use some strategies to improve the efficacy.
For patients who have received strong immunosuppressive therapy or high-intensity chemotherapy, the number of T lymphocytes may be sufficient, but the quality and activity may not be high
.
If the condition permits, patients can be allowed to rest properly, and CAR-T treatment can be performed after the activity and function of T lymphocytes have been restored to a certain extent, which may improve the efficacy
.
There are also some studies that have found that if the CAR-T cell expansion in the body is not satisfactory after the patient's infusion of CAR-T cells, other methods can be used for intervention, such as combination medication, which can stimulate the expansion of CAR-T cells in the body.
, Helps to improve curative effect
.
Yimaitong: In clinical practice, how to monitor and manage patients' adverse reactions after CAR-T cell infusion? Professor Song Yuqin's CAR-T treatment-related adverse events can be divided into two categories
.
One type is clearing-out treatment, that is, related adverse events caused by fludarabine + cyclophosphamide treatment
.
Patients may have bone marrow suppression, such as leukopenia, anemia, and thrombocytopenia, and symptomatic and supportive treatment can be performed
.
The other is the adverse events after CAR-T cell reinfusion, mainly CRS and neurotoxicity, which require special attention in the clinic
.
For such adverse reactions, many centers are very experienced.
If a patient develops CRS or neurotoxicity, tocilizumab and glucocorticoids should be used, and both have routine treatment procedures
.
Our department also has very practical diagnosis and treatment standards.
It is very important for every young doctor, whether it is a graduate student or a first-line doctor, to learn this process first
.
Of course, cytokines must be closely monitored during treatment to guide clinical treatment
.
If the patient's adverse event is more serious, it is necessary to communicate with the intensive care unit in time and deal with it in a timely manner, so that the patient can safely pass the reaction period of the adverse event, and finally obtain a good effect
.
Yimaitong: Could you please talk about the future industry standard for CAR-T full-process management? Professor Song Yuqin Professor Song Yuqin: In the future, CAR-T whole-process management practices should start with patient screening, and planning should even begin at the previous stage of screening
.
Because the preliminary treatment is very important for the subsequent success of CAR-T treatment, or to improve the efficacy of CAR-T
.
In addition, for patients, what is the most suitable bridging treatment, the treatment of adverse events after CAR-T cell reinfusion, and there may even be some differences in the treatment of different CAR-T products.
We must pay attention to it.
.
In addition, long-term follow-up is also very important
.
Some patients in our department started treatment in 2013 and continue to remission now, with the longest follow-up time of more than five or six years
.
We need to pay attention to many issues, such as whether CAR-T cells continue to expand in the patient's body, whether the expansion is under control, and whether the patient's condition is stable
.
In addition, some patients still have fertility needs and are even worried about whether a second tumor will occur
.
The whole process of CAR-T management is 15-17 years in accordance with the requirements of clinical trials, which is a long-term follow-up process
.
In the future, more and more CAR-T products will be on the market, and more and more patients will be treated with CAR-T, which may require 15-20 years of long-term follow-up
.
I think it is necessary to establish a registration center or reporting system to carry out long-term follow-up of patients to control the trends and safety of CAR-T treatment at any time
.
Poke "read the original text", we make progress together
