SAN DIEGO, Dec. 2, 2018 /PRNewswire/ -- The 60th American Society of Hematology (ASH) Annual Meeting, the largest international
CAR T-cell therapy involves genetically modifying a patient's T-cells to recognize a specific antigen found on tumor cells and kill them.
During a podium presentation, Dr. Peihua Lu reported results of a clinical study titled "A Feasibility and Safety Study of CD19 and CD22 Chimeric Antigen Receptors-Modified T Cell Cocktail for Therapy of B Cell Acute Lymphoblastic Leukemia (B-ALL)." Fifteen patients (including five children and 10 adults) with CD19+CD22+ relapsed or refractory B-ALL were treated at Lu Daopei Hospital with the chemotherapy drugs fludarabine and cyclophosphamide, followed by a cocktail of CAR T-cell infusion with CD19 CAR-T and CD22 CAR-T. The CD22 CAR construct includes a single chain variable fragment (ScFv) from a monoclonal antibody against the human protein PD-L1 which attempts to reduce the exhaustion of CAR T-cells by blocking the PD-1/PD-L1 pathway, thereby enhancing the persistence of infused CAR T-cell engraftment. Between days 20 to 30, after CAR-T infusion, 15 out of 15 patients (100%) achieved complete remission (CR) or incomplete CR (CRi) while 14 out of 15 patients (93.3%) had negative minimal residual disease (MRD). In this cohort of patients with very high CR rate, they also experienced very low treatment-related toxicity: 13 out of 15 patients developed cytokine release syndrome (CRS), a systemic inflammatory response, at a grade <2, and central nervous system (CNS) Grade 0. Dr. Lu concluded that this study has demonstrated technical feasibility, high efficacy and low toxicities of CD19 and CD22 CAR-T cocktail in treating patients with CD19+CD22+ relapsed or refractory B-ALL.
Another clinical study performed at the Lu Daopei Hospital, titled "Efficacy and Safety of CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy for B-Cell Acute Lymphoblastic Leukemia (B-ALL) in a Large Cohort Including Patients with Extramedullary Disease (EMD), High Leukemia Burden (HLB), BCR-ABL (+) Mutation, TP53 Mutation, and Post-Transplant Relapse" was presented by Dr. Xian Zhang at this ASH Annual Meeting as an oral presentation. A cohort of 87 B-ALL patients with high-risk features (including those listed in the title) were given a single infusion of CD19 CAR T-cells. After 30 days of CAR-T therapy, 76 out of 83 patients (91.6%) achieved CR or Cri, and 70 out of 76 patients achieved MRD-negative CR. One-year overall survival (OS) was 76.5% and relapse-free survival (RFS) was 62.6%. This cohort of patients also experienced low side effect and toxicity profile: grade 0-2 CRS incidence was 82%, and grade 3-4 was only 16%. Dr. Zhang concluded that this cohort of relapsed/refractory B-ALL patients with high-risk features (such as EMD, HLB, BCR-ABL+, TP53+, and relapse after allogeneic hematopoietic stem cell transplant) achieved high CR rate with manageable CRS after CD19 CAR-T treatment. Overall, RFS was superior for patients bridging to allogeneic hematopoietic stem cell transplant after CAR T-cell treatment than for patients receiving CAR-T alone.
These two studies from Lu Daopei Hospital have demonstrated superior clinical outcomes and high safety profile in CAR-T therapy. Both presentations by Dr. Peihua Lu and Dr. Xian Zhang were very well received by their peer audience.
Source: Yadira Galindo Health Journalist Contact: Crescendo Communications
SOURCE Lu Daopei Hospital
Subscribe to our Free Newsletters!