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▎The content team editor of WuXi AppTec.
CAR (Chimeric Antigen Receptor)-T Cell Therapy is a type of cellular immunotherapy, which uses the power of the body’s own immune system to identify the patient’s T cells in vitro and infused into the patient’s body.
And attack cancer cells in the human body
.
Ciltacabtagene autoleucel (cilta-cel) is a CAR-T cell therapy with a differentiated structure.
It has recently obtained priority review qualification granted by the US FDA for multiple myeloma
.
Recently, the key 1b/2 CARTITUDE-1 research results of cilta-cel were published in The Lancet
.
Studies have shown that a single infusion of cilta-cel shows early, deep and lasting remission in patients with relapsed or refractory multiple myeloma
.
The total remission rate of this therapy is 97%, and most patients achieve the first remission within one month of infusion and the safety is controllable
.
Screenshot source: The Lancet Usually, patients with multiple myeloma who have been treated with proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies will eventually relapse or become resistant to these therapies
.
A retrospective study report showed that among refractory patients who received the above three types of therapies, the overall response rate was only 31%, and the median overall survival was only 9.
3 months
.
Therefore, innovative therapies are still needed to improve the long-term outcomes of such patients
.
Cilta-cel contains a 4-1BB costimulatory domain and two antibody domains targeting B cell maturation antigen (BCMA), which has the ability to promote the expansion of CD8-positive T cells
.
BCMA is a protein highly expressed on myeloma cells
.
▲Schematic diagram of the structure of Cilta-cel (picture source: Legendary Bio's official website) The research team comes from Mayo Clinic Cancer Center.
The researchers recruited 113 patients with polymorphism aged ≥18 years and a physical status score of 0 or 1.
Patients with myeloma
.
These patients have previously received at least third-line standard drug treatment or have dual resistance to proteasome inhibitors and immunomodulatory drugs, and have received proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibody treatment
.
The subject’s lymphocytes were depleted 5-7 days after a single infusion of cilta-cel (target dose of 0.
75×106 CAR-positive live T cells/kg)
.
The primary endpoints are the safety and recommended dose of the phase 1b trial, and the overall response rate (ORR) of the phase 2 trial in all patients receiving treatment.
The key secondary endpoints are the duration of remission and progression-free survival
.
The study found that after a median follow-up of 12.
4 months, among 97 patients who received the phase 2 recommended dose (0.
75×106 CAR-positive live T cells/kg) cilta-cel infusion, the overall response rate was 97%, of which 65 cases (67%) achieved complete remission, and the median time to first remission was 1 month
.
The 12-month progression-free survival rate was 77%, and the 12-month overall survival rate was 89%
.
Over time, the remission continued to deepen, and the median duration of remission (95% confidence interval greater than 15.
9 months) and progression-free survival (95% confidence interval greater than 16.
8 months) have not yet been reached
.
Grade 3-4 hematological adverse events were neutropenia, anemia, leukopenia, thrombocytopenia and lymphopenia
.
Ninety-two out of 97 patients developed cytokine release syndrome; the median time to cytokine release syndrome was 7 days, and the median duration was 4 days
.
Except for one patient who developed grade 5 cytokine release syndrome and hemophagocytic lymphohistiocytosis, all patients had cytokine release syndrome resolved
.
Twenty patients (21%) developed CAR-T cell neurotoxicity
.
There were 14 deaths in the study; 6 died of treatment-related adverse events, 5 died of disease progression, and 3 died of treatment-unrelated adverse events
.
Yi Lin, the first author of the study and PhD in Hematology from Miaoyou Medical International, said: “It is very exciting for patients treated with cilta-cel to have a high remission rate and progression-free survival
.
A
better understanding of the experience in this therapy The clinical characteristics of patients with long-lasting remission and the mechanisms behind relapsed patients are very important
.
"At present, cilta-cel is also exploring the effect of treating multiple myeloma patients at an earlier stage.
Patients with multiple myeloma bring more treatment options
.
Recommended reading NEJM: 60% of patients are still in remission after 5 years, and the long-term efficacy of CAR-T therapy is the second leading cause of disability! Over 80% of migraine sufferers are under-managed.
Three articles in The Lancet detail the progress of diagnosis and treatment.
JAMA: The 20-year traditional strategy should be refreshed! For the prevention of ischemic stroke, these six drugs are expanding the treatment of multiple choice questions.
Source: 123RF Reference: [1] Researchers study potential new CAR-T cell therapy for multiple myeloma.
Retrieved JUNE 26, 2021, from https://medicalxpress .
com/news/2021-06-potential-car-t-cell-therapy-multiple.
html.
[2] Berdeja, JG, Madduri, D.
, Usmani, SZ, Jakubowiak, A.
, Agha, M.
, Cohen , AD, .
.
.
& Jagannath, S.
(2021).
Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b /2 open-label study.
The Lancet.
[3] Janssen Announces US FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma.
Retrieved June 1, 2021, from https://
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
CAR (Chimeric Antigen Receptor)-T Cell Therapy is a type of cellular immunotherapy, which uses the power of the body’s own immune system to identify the patient’s T cells in vitro and infused into the patient’s body.
And attack cancer cells in the human body
.
Ciltacabtagene autoleucel (cilta-cel) is a CAR-T cell therapy with a differentiated structure.
It has recently obtained priority review qualification granted by the US FDA for multiple myeloma
.
Recently, the key 1b/2 CARTITUDE-1 research results of cilta-cel were published in The Lancet
.
Studies have shown that a single infusion of cilta-cel shows early, deep and lasting remission in patients with relapsed or refractory multiple myeloma
.
The total remission rate of this therapy is 97%, and most patients achieve the first remission within one month of infusion and the safety is controllable
.
Screenshot source: The Lancet Usually, patients with multiple myeloma who have been treated with proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies will eventually relapse or become resistant to these therapies
.
A retrospective study report showed that among refractory patients who received the above three types of therapies, the overall response rate was only 31%, and the median overall survival was only 9.
3 months
.
Therefore, innovative therapies are still needed to improve the long-term outcomes of such patients
.
Cilta-cel contains a 4-1BB costimulatory domain and two antibody domains targeting B cell maturation antigen (BCMA), which has the ability to promote the expansion of CD8-positive T cells
.
BCMA is a protein highly expressed on myeloma cells
.
▲Schematic diagram of the structure of Cilta-cel (picture source: Legendary Bio's official website) The research team comes from Mayo Clinic Cancer Center.
The researchers recruited 113 patients with polymorphism aged ≥18 years and a physical status score of 0 or 1.
Patients with myeloma
.
These patients have previously received at least third-line standard drug treatment or have dual resistance to proteasome inhibitors and immunomodulatory drugs, and have received proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibody treatment
.
The subject’s lymphocytes were depleted 5-7 days after a single infusion of cilta-cel (target dose of 0.
75×106 CAR-positive live T cells/kg)
.
The primary endpoints are the safety and recommended dose of the phase 1b trial, and the overall response rate (ORR) of the phase 2 trial in all patients receiving treatment.
The key secondary endpoints are the duration of remission and progression-free survival
.
The study found that after a median follow-up of 12.
4 months, among 97 patients who received the phase 2 recommended dose (0.
75×106 CAR-positive live T cells/kg) cilta-cel infusion, the overall response rate was 97%, of which 65 cases (67%) achieved complete remission, and the median time to first remission was 1 month
.
The 12-month progression-free survival rate was 77%, and the 12-month overall survival rate was 89%
.
Over time, the remission continued to deepen, and the median duration of remission (95% confidence interval greater than 15.
9 months) and progression-free survival (95% confidence interval greater than 16.
8 months) have not yet been reached
.
Grade 3-4 hematological adverse events were neutropenia, anemia, leukopenia, thrombocytopenia and lymphopenia
.
Ninety-two out of 97 patients developed cytokine release syndrome; the median time to cytokine release syndrome was 7 days, and the median duration was 4 days
.
Except for one patient who developed grade 5 cytokine release syndrome and hemophagocytic lymphohistiocytosis, all patients had cytokine release syndrome resolved
.
Twenty patients (21%) developed CAR-T cell neurotoxicity
.
There were 14 deaths in the study; 6 died of treatment-related adverse events, 5 died of disease progression, and 3 died of treatment-unrelated adverse events
.
Yi Lin, the first author of the study and PhD in Hematology from Miaoyou Medical International, said: “It is very exciting for patients treated with cilta-cel to have a high remission rate and progression-free survival
.
A
better understanding of the experience in this therapy The clinical characteristics of patients with long-lasting remission and the mechanisms behind relapsed patients are very important
.
"At present, cilta-cel is also exploring the effect of treating multiple myeloma patients at an earlier stage.
Patients with multiple myeloma bring more treatment options
.
Recommended reading NEJM: 60% of patients are still in remission after 5 years, and the long-term efficacy of CAR-T therapy is the second leading cause of disability! Over 80% of migraine sufferers are under-managed.
Three articles in The Lancet detail the progress of diagnosis and treatment.
JAMA: The 20-year traditional strategy should be refreshed! For the prevention of ischemic stroke, these six drugs are expanding the treatment of multiple choice questions.
Source: 123RF Reference: [1] Researchers study potential new CAR-T cell therapy for multiple myeloma.
Retrieved JUNE 26, 2021, from https://medicalxpress .
com/news/2021-06-potential-car-t-cell-therapy-multiple.
html.
[2] Berdeja, JG, Madduri, D.
, Usmani, SZ, Jakubowiak, A.
, Agha, M.
, Cohen , AD, .
.
.
& Jagannath, S.
(2021).
Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b /2 open-label study.
The Lancet.
[3] Janssen Announces US FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma.
Retrieved June 1, 2021, from https://
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
