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The FDA granted regenerative medicine advanced therapy designation to CTX110, a chimeric antigen receptor T-cell therapy in development for treatment of relapsed or refractory B-cell malignancies.CTX110 (CRISPR Therapeutics) is an allogeneic, CD19-targeted, CRISPR/Cas9 gene-edited CAR T-cell therapy designed to treat adults with CD19-positive B-cell malignancies, including non-Hodgkin lymphoma, 
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Although CAR T-cell therapies have demonstrated unprecedented activity in patients with heavily pretreated relapsed/refractory hematologic malignancies, they are marked by a significant risk of infections and may limit the efficacy of COVID-19 vaccines.
BigField GEG Tech's insight:
Although CAR T cell therapies have demonstrated unprecedented activity in patients with relapsed/refractory heavily pretreated hematologic malignancies, they are marked by a significant risk of infections and may limit the efficacy of COVID-19 vaccines. Data are needed to explain how to optimize COVID-19 vaccination and booster strategies in recipients of CAR T cell therapy, according to the results of a review published in Transplantation and Cellular Therapy. The studies suggest that COVID-19 vaccine responses may be significantly reduced in patients receiving CAR T-cell therapy compared with those undergoing allo-GCSH. Early data suggest that adequate humoral and cellular responses to COVID-19 vaccines may not be achieved in patients with hematologic malignancies. Thus, important research is needed to determine how recipients of CAR T cell therapy respond to COVID-19 vaccinations, particularly as booster vaccine dosing and heterologous primary boosting strategies become more updated.
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The FDA has granted Advanced Regenerative Medicine Therapy designation to CTX110, a CAR T cell therapy in development for the treatment of relapsed or refractory B-cell malignancies. CTX110 (CRISPR Therapeutics) is an allogeneic, CD19-targeted, CRISPR/Cas9-modified CAR T cell therapy designed to treat adults with CD19-positive B-cell malignancies, including non-Hodgkin's lymphoma, B-cell lymphoma and B-cell acute lymphoblastic leukemia. The FDA based the Advanced Therapy in Regenerative Medicine designation on the results of the ongoing multi-center Phase 1 CARBON trial. The dose escalation study is designed to evaluate the safety and efficacy of the treatment in adult patients with relapsed or refractory CD19-positive B-cell malignancies who have received at least two prior lines of therapy.
Initial data released by the manufacturer in October showed an overall response rate of 58% for dose levels 2, 3, and 4 on an intention-to-treat basis, with a complete response rate of 38% in these patients. The treatment had a favorable safety profile, and four of the nine patients who achieved a complete response by day 28 remained in remission 6 months after treatment.
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