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Hemorrhagic cystitis (HC) is one of the common complications of patients receiving allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
It often causes hematuria and urinary tract irritation.
Although HC does not affect the survival of the patient after transplantation, it has a serious impact The patient’s quality of life, prolonged hospital stay and increased medical expenses, severe cases may lead to renal insufficiency or even life-threatening.
Among them, delayed HC generally occurs after hematopoietic reconstitution, and is mainly related to viral infection.
The most common is BK virus (BKV) infection, which currently lacks effective specific treatments.
Professor Amanda Olson and others conducted an early clinical study to evaluate the efficacy and safety of the third-party BKV-specific cytotoxic T lymphocytes (CTL) with the highest HLA matching for the treatment of BKV-related HC (BKV-HC) after Allo-HSCT Sex.
Yimaitong organizes its main contents as follows for the reference of readers.
Research background and purpose Allo-HSCT patients are prone to opportunistic infections due to immunosuppressive effects.
BKV is a human polyoma virus.
The targets of BKV-specific cellular immunity include different BKV antigens.
In immunocompromised hosts, for example, after Allo-HSCT, the changes in BKV-specific T cell responses are caused by BKV reactivation.
Key factor.
However, the exact pathophysiological mechanism behind this phenomenon is still unclear.
The clinical manifestations of BKV activation vary from asymptomatic uremia to hemorrhagic and non-hemorrhagic cystitis, ureteral stenosis, and nephritis, which may lead to prolonged hospital stay, renal insufficiency and increased mortality.
Previous studies have shown that the incidence of BKV activation after Allo-HSCT is 5%-52%, and the incidence may be higher in Allo-HSCT patients receiving alternative donors.
Unfortunately, there is currently no effective therapy for BKV-HC.
Based on this, Professor Amanda Olson and others carried out a clinical trial to explore the safety and effectiveness of viral CTL therapy against 5 BKV antigens for BKV-HC patients after Allo-HSCT.
Research method This clinical trial evaluated the third-party BKV CTL with the highest HLA matching degree obtained from 26 healthy donors and infused it into 59 patients who developed BKV-HC after Allo-HSCT to evaluate the treatment.
The feasibility, safety and effectiveness of the system.
Study Results 01 Patient characteristics This study chose a single virus expansion method to prepare BKV-CTL for clinical trials.
Between October 2015 and September 2019, 59 consecutive BKV-HC patients after Allo-HSCT received BKV-CTL treatment in the study.
The median dose of infusion was 2×105 CD3+ T cells/kg, and the median of HLA allele matching was 2.
02 Patients with curative effects can quickly obtain therapeutic remission, in which the median time to obtain partial remission (PR) and/or complete remission (CR) is 14 days, and the median time to obtain CR is 21 days.
On the 14th day after the first infusion, the proportion of patients who can be assessed to achieve PR or CR is 67.
7% (95% CI: 54.
4-9.
4), and the clinical symptoms have improved significantly; the proportion of patients who are expected to achieve CR 45 days after infusion It is 70% (95%CI: 54.
5-81.
7).
The overall survival (OS) rate of the patients at 12 months was 55.
4% (95% CI: 43.
9-69.
8).
Five patients died due to deterioration of blood system diseases; five patients withdrew from the study and received other treatments.
Further analysis results show that compared with historical controls, BKV-CTL treatment can enable BKV-HC patients to obtain a higher proportion of CR, CR and/or PR.
The BKV viral load in the urine of the patients was monitored by qPCR.
The results showed that after the infusion of BKV-CTL treatment, it was observed that the BKV viral load in the treated patients was significantly reduced. In addition, the BKV T cell response from BKV CTL products lasted as long as 3 months.
03 Safety After using BKV-CTL, patients in this study did not observe any possible or certain side effects attributable to CTL, including infusion-related toxicity, pancytopenia or transplant failure.
The patient did not observe any new grade 3 or 4 graft-versus-host disease (GVHD) after BKV-CTL infusion.
One patient developed Grade 2 skin GVHD 7 days after CTL infusion, and improved after topical steroid treatment.
Another patient had a history of grade 1 skin GVHD, and developed grade 3 gastrointestinal (GI) GVHD 64 days after BKV-CTL infusion, and was controlled after treatment with systemic corticosteroids.
During the 12-month follow-up period, a total of 9 patients developed chronic GVHD.
It is worth noting that treatment with steroids due to GVHD did not lead to recurrence of BKV-HC in patients.
Research conclusions The research shows that third-party BKV-CTL is an efficient and safe treatment for patients with BKV-HC after Allo-HSCT.
References: Amanda Olson, Ruitao Lin, David Marin, et al.
Third-Party BK Virus-Specific Cytotoxic T Lymphocyte Therapy for Hemorrhagic Cystitis Following Allotransplantation.
J Clin Oncol.
2021 Apr 30; JCO2002608.
Stamp "Read the original", let's work together progress
It often causes hematuria and urinary tract irritation.
Although HC does not affect the survival of the patient after transplantation, it has a serious impact The patient’s quality of life, prolonged hospital stay and increased medical expenses, severe cases may lead to renal insufficiency or even life-threatening.
Among them, delayed HC generally occurs after hematopoietic reconstitution, and is mainly related to viral infection.
The most common is BK virus (BKV) infection, which currently lacks effective specific treatments.
Professor Amanda Olson and others conducted an early clinical study to evaluate the efficacy and safety of the third-party BKV-specific cytotoxic T lymphocytes (CTL) with the highest HLA matching for the treatment of BKV-related HC (BKV-HC) after Allo-HSCT Sex.
Yimaitong organizes its main contents as follows for the reference of readers.
Research background and purpose Allo-HSCT patients are prone to opportunistic infections due to immunosuppressive effects.
BKV is a human polyoma virus.
The targets of BKV-specific cellular immunity include different BKV antigens.
In immunocompromised hosts, for example, after Allo-HSCT, the changes in BKV-specific T cell responses are caused by BKV reactivation.
Key factor.
However, the exact pathophysiological mechanism behind this phenomenon is still unclear.
The clinical manifestations of BKV activation vary from asymptomatic uremia to hemorrhagic and non-hemorrhagic cystitis, ureteral stenosis, and nephritis, which may lead to prolonged hospital stay, renal insufficiency and increased mortality.
Previous studies have shown that the incidence of BKV activation after Allo-HSCT is 5%-52%, and the incidence may be higher in Allo-HSCT patients receiving alternative donors.
Unfortunately, there is currently no effective therapy for BKV-HC.
Based on this, Professor Amanda Olson and others carried out a clinical trial to explore the safety and effectiveness of viral CTL therapy against 5 BKV antigens for BKV-HC patients after Allo-HSCT.
Research method This clinical trial evaluated the third-party BKV CTL with the highest HLA matching degree obtained from 26 healthy donors and infused it into 59 patients who developed BKV-HC after Allo-HSCT to evaluate the treatment.
The feasibility, safety and effectiveness of the system.
Study Results 01 Patient characteristics This study chose a single virus expansion method to prepare BKV-CTL for clinical trials.
Between October 2015 and September 2019, 59 consecutive BKV-HC patients after Allo-HSCT received BKV-CTL treatment in the study.
The median dose of infusion was 2×105 CD3+ T cells/kg, and the median of HLA allele matching was 2.
02 Patients with curative effects can quickly obtain therapeutic remission, in which the median time to obtain partial remission (PR) and/or complete remission (CR) is 14 days, and the median time to obtain CR is 21 days.
On the 14th day after the first infusion, the proportion of patients who can be assessed to achieve PR or CR is 67.
7% (95% CI: 54.
4-9.
4), and the clinical symptoms have improved significantly; the proportion of patients who are expected to achieve CR 45 days after infusion It is 70% (95%CI: 54.
5-81.
7).
The overall survival (OS) rate of the patients at 12 months was 55.
4% (95% CI: 43.
9-69.
8).
Five patients died due to deterioration of blood system diseases; five patients withdrew from the study and received other treatments.
Further analysis results show that compared with historical controls, BKV-CTL treatment can enable BKV-HC patients to obtain a higher proportion of CR, CR and/or PR.
The BKV viral load in the urine of the patients was monitored by qPCR.
The results showed that after the infusion of BKV-CTL treatment, it was observed that the BKV viral load in the treated patients was significantly reduced. In addition, the BKV T cell response from BKV CTL products lasted as long as 3 months.
03 Safety After using BKV-CTL, patients in this study did not observe any possible or certain side effects attributable to CTL, including infusion-related toxicity, pancytopenia or transplant failure.
The patient did not observe any new grade 3 or 4 graft-versus-host disease (GVHD) after BKV-CTL infusion.
One patient developed Grade 2 skin GVHD 7 days after CTL infusion, and improved after topical steroid treatment.
Another patient had a history of grade 1 skin GVHD, and developed grade 3 gastrointestinal (GI) GVHD 64 days after BKV-CTL infusion, and was controlled after treatment with systemic corticosteroids.
During the 12-month follow-up period, a total of 9 patients developed chronic GVHD.
It is worth noting that treatment with steroids due to GVHD did not lead to recurrence of BKV-HC in patients.
Research conclusions The research shows that third-party BKV-CTL is an efficient and safe treatment for patients with BKV-HC after Allo-HSCT.
References: Amanda Olson, Ruitao Lin, David Marin, et al.
Third-Party BK Virus-Specific Cytotoxic T Lymphocyte Therapy for Hemorrhagic Cystitis Following Allotransplantation.
J Clin Oncol.
2021 Apr 30; JCO2002608.
Stamp "Read the original", let's work together progress
