anti-CD19 CAR-T cell therapy / Wuhan Sian Medical Tech, ProMab Biotechnology - LARVOL DELTA

Long-Term Follow-up of Humanized and Murine CD19 CAR-T Cell Therapy for B-Cell Malignancies (ASH 2023) - "Results indicate that humanized CAR-T therapy showed better safety and durable efficacy, especially in patients with higher tumor burden in bone marrow. Moreover, it could overcome immunogenicity-induced CAR-T resistance, providing treatment options for patients' failures of CAR-T therapies."

CAR T-Cell Therapy • Preclinical • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Transplantation • ABL1 • BCR

ANTI-CD19 CAR-T THERAPY BRIDGING TO ALLO-HSCT IMPROVES LONG-TERM OUTCOME OF B-ALL PATIENTS WITH HIGH LEUKEMIA BURDEN OR POOR PROGNOSTIC MARKERS (EHA 2019) - P1/2; "...New strategies that can help CAR-T therapy achieve lasting effect are urgently warranted.Aims Our study aimed to answer the question that whether subsequent allo-HSCT could improve the long-term prognosis of the minimal residual disease-negative (MRD-) CR patients after CAR-T therapy. Methods In the first stage, patients received split doses of CAR-T cells after lymphodepleting chemotherapy, consisting of fludarabine and cyclophosphamide. In the second stage, MRD- CR patients who had no history of allo-HSCT and had no contraindications or other restrictions would, on their own accord, receive allo-HSCT from 1 to 3 months after CAR-T therapy.Results 58 r/r B-ALL patients were treated with anti-CD19 CAR-T cells, and 51 (87.9%) achieved complete remission (CR) (47 MRD- CR)...Patients with high pre-infusion MRD or with poor prognostic markers can benefit from the early consolidative allo-HSCT after CAR-T therapy. Trials were registered at www.clinicaltrials.gov as #..."

Biomarker • Clinical • IO Biomarker

Humanized CD19 CAR T-Cell Therapy Shows Early Promise as Treatment of Hematologic Malignancies (Targeted Oncology) - P1, N=10; NCT04008251; Sponsor: Wuhan Sian Medical Technology Co., Ltd; "An investigator-initiated trial (NCT04008251) of ProMab Biotechnology’s humanized CD19-directed chimeric antigen receptor (CAR) T-cell therapy has been completed, demonstrating the therapy may be a safe and effective treatment for patients with hematologic malignancies...Ten patients with relapsed/refractory CD19-positive B-cell malignant hematological tumors, which included acute lymphoblastic leukemia and chronic lymphocytic leukemia, and non-Hodgkin lymphoma...Cytokine release syndrome....was significantly reduced with the humanized CD19 CAR T-cell therapy. Five patients experienced level 1 CRS, and 4 patients did not have CRS at all."

Cytokine release syndrome • P1 data • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

ProMab Presents Promising Results in Humanized CD19 CAR-T Cells Trial (Businesswire) - P1, N=10; Sponsor: Wuhan Sian Medical Technology Co; Ltd; "ProMab Biotechnology, Inc...announced...it has successfully completed an investigator initiated trail (IIT) for CAR-T cell therapy. The study was conducted at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology...using ProMab’s humanized CD19 CAR-T cells for 10 patients with relapsed and refractory CD19-positive B-cell malignant hematological tumors, including acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and patients with non-Hodgkin's lymphoma (NHL)...Among the 10 cases studied, 7 patients were in continuous remission....The study also demonstrated that the Cytokine Release Syndrome (CRS) side effects were significantly reduced, specifically; there were 5 patients with level 1 side effects and 4 patients without CRS side effects at all. The results have demonstrated that the humanized CD19 CAR-T cell therapy is safe and effective."

Cytokine release syndrome • P1 data • Acute Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology