[Asia Economy Reporter Chunhee Lee] SCM Life Sciences' (SCM Life Sciences) U.S. affiliate CoImmune announced on the 15th that it presented interim results of the Phase 1/2 clinical trial of the chimeric antigen receptor (CAR) modified cytokine-induced killer (CIK) cell therapy ‘CARCIK-CD19’ at the American Society of Hematology (ASH) held from the 10th to 13th (local time) in New Orleans, USA. This year marks the 64th ASH, a global hematology society with more than 18,000 clinicians and scientists from over 100 countries worldwide.
CoImmune stated that in the Phase 1/2 clinical trial using the CAR-CIK cell platform targeting patients with relapsed B-cell acute lymphoblastic leukemia after hematopoietic stem cell transplantation, they confirmed anti-leukemia activity along with safety and a tendency to reduce the risk of leukemia relapse.
The clinical trial, conducted in collaboration between pediatrics and hematology departments in Italy from February 2018 to August last year, involved 27 patients with relapsed B-cell acute lymphoblastic leukemia after hematopoietic stem cell transplantation (4 pediatric and 23 adult patients).
Among the 27 clinical trial subjects, 18 patients (66.7%) achieved complete remission (CR), meaning no evidence of cancer was detected. Among them, 14 patients (77.8%) showed negativity for minimal residual disease (MRD).
Notably, among 21 patients in two groups who received high doses of cells, 16 patients (76.2%) reached CR, and among them, 13 patients (81.3%) who received the highest dose confirmed MRD negativity. After treatment with CARCIK-CD19, no additional graft-versus-host disease occurred, and no dose-limiting toxicity was observed.
The impact of CARCIK-CD19 cell proliferation, differentiation, and expansion on clinical outcomes was also evaluated. Among the clinical trial participants, CARCIK-CD19 cells were detected in vivo for up to 12 months in 20 patients, which was confirmed to be longer compared to existing CAR-T therapies.
Charles Nicolet, CEO of CoImmune, said, “Immunotherapy offers higher efficacy and improved safety compared to traditional approaches to cancer treatment,” adding, "these clinical results confirmed the potential to further improve treatment outcomes for patients with B-cell acute lymphoblastic leukemia and acute myeloid leukemia."
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