CBMG Holdings' Novel Anti-CD20 CAR-T Cell Therapy Shows Promising Safety and Efficacy in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma Patients Following Relapse to an anti-CD19 CAR-T Therapy
HONG KONG, June 10, 2021 /PRNewswire/ -- CBMG Holdings (or the "Company"), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, today announced early promising safety and efficacy results of C-CAR066, a novel second generation chimeric antigen receptor T (CAR-T) therapy targeting CD20 antigen in relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) that has failed to an anti-CD19 CAR-T therapy. Patients who fail anti-CD19 CAR-T therapy generally have a dismal prognosis and are an important group with high unmet medical needs. This abstract was recently presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting by the Principal Investigator (PI) of the study, Aibin Liang, M.D., Professor of Department of Hematology, Shanghai Tongji Hospital, Tongji University School of Medicine, China.
"C-CAR066 preliminary data has shown an early promising therapeutic index in patients with r/r B-NHL after relapsing to an anti-CD19 CAR-T therapy," said Tony (Bizuo) Liu, Chairman and CEO of CBMG Holdings. "These early clinical data suggest that C-CAR066 could potentially provide a solution to address the highly unmet medical need in B-NHL patients that have failed to respond to anti-CD19 CAR-T therapy".
About the Study
The Phase I clinical trials (NCT04036019, NCT04316624) were conducted in Shanghai Tongji Hospital and Institute of Hematology & Blood Diseases Hospital in Tianjin, China, to evaluate the safety and efficacy of C-CAR066 in subjects with r/r B-NHL who were previously treated with and failed after an anti-CD19 CAR-T therapy.
Of the 10 patients enrolled in the study, the median age was 55.5 (range, 41-67) years. The median number of prior lines of therapy was 5 (range, 2-6). Two patients (20%) underwent autologous stem cell transplant (ASCT). The median duration of response to prior anti-CD19 CAR-T therapy was 2.1 months (range:0.7~12.6).
Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were graded according to ASTCT 2019 criteria. 9/10 patients experienced CRS, in which 8 were graded as either grade 1 or grade 2. One patient had grade 4 CRS and recovered after treatment with tocilizumab and corticosteroids. No patients experienced any ICANS event. Grade ≥3 neutropenia, anemia, thrombocytopenia, and infections were reported in 80%, 50%, 30%, and 10% of patients, respectively.
At a median follow-up of 4.2 months (range, 1.2-11.7), the best overall response rate was 100%, with 70.0% (7/10) reaching complete response (CR). Median time to response was 1.0 month (range, 0.9-2.7). Median time to CR was 2.7 months (range, 0.9-2.9). Median duration of response was not reached by the cutoff date. By the cutoff date, 4 patients (3 PR, 1 CR) had experienced disease progression. Among them, two patients relapsed due to loss of CD19 and CD20 antigens on tumor cell. One patient relapsed due to the loss of CAR-T cell expansion and proliferation 2 months post C-CAR066 infusion. 6 patients continue to respond to C-CAR066 treatment at the date of the cutoff. Among them, 4 patients remained in CR after 10 months post C-CAR066 infusion.
About CBMG Holdings
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SOURCE CBMG Holdings