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On January 12, 2022, Sibiman Bio announced that the U.
S.
FDA granted C-CAR039 Regenerative Medicine Advanced Therapy Designation (RMAT) and Fast Track designation for the treatment of relapsed/refractory diffuse large B-cell lymphoma (r/ rDLBCL) patients
.
C-CAR039 is a novel autologous bispecific CAR-T cell therapy targeting both CD19 and CD20 antigens, which can effectively eliminate CD19/CD20 single-positive or double-positive tumor cells in vivo and in vitro
DLBCL is an aggressive non-Hodgkin lymphoma (NHL) and the most common histological subtype of NHL
.
Previously, an investigator-initiated clinical trial in China demonstrated a favorable safety profile for C-CAR039 in the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-cell NHL), and Encouraging clinical efficacy
Specifically, as of April 20, 2021, a total of 34 patients had received C-CAR039 cell therapy, the patients had received a median of 3 previous lines of therapy, the median age was 55.
5 years, and 75% of the cancers were Ann Arbor stage III /Stage IV
.
Among them, 28 patients were eligible for safety analysis and evaluation, and 27 patients were eligible for efficacy analysis and evaluation
In terms of safety, 92.
9% (n=26/28) of patients developed cytokine release syndrome (CRS), of which 2 patients (n=2/26) developed grade 1 immune effector cell-related neurotoxicity syndrome ( ICANS)
.
Sibeman Bio will continue to evaluate patients with longer follow-up
References:
[1] CBMG Receives FDA Regenerative Medicine Advanced Therapy and Fast Track Designations for Bi-Specific Anti-CD19/CD20 CAR-T Cell Therapy for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma.
(Original abridged)
