Sibiman's dual-target CAR-T therapy received FDA regenerative medicine advanced therapy designation

Introduction: Recently, Cibiman Biotechnology, a biopharmaceutical company focusing on the development of innovative cell therapies, announced that the U.
S.
FDA has granted its C-CAR039 Regenerative Medicine Advanced Therapy Designation (RMAT) and Fast Track designation for the treatment of relapsed/refractory disease.
Patients with diffuse large B-cell lymphoma (r/r DLBCL)
.

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
.

C-CAR039 is a novel second-generation 4-1BB dual-target CAR-R with self-developed patent-protected and optimized bispecific antigen-binding domains, which can simultaneously act on CD19 and CD20 dual targets.
Effectively clears CD19/CD20 single-positive or double-positive tumor cells in vivo and in vitro
.

Early clinical results from a trial of C-CAR039 in China demonstrated exciting efficacy and favorable safety data for C-CAR039 in r/r B-cell NHL
.

 According to relevant statistics, as of April 20, 2021, a total of 34 patients had received C-CAR039 cell therapy, of which 28 patients underwent safety analysis and 27 underwent efficacy analysis
.

The median age of the patients was 55.
5 years, the median number of previous lines of therapy was 3, 75% of patients had An Arbor stage III/IV, and 5 patients (17.
9%) received bridging therapy
.

 The data showed that cytokine release syndrome (CRS) occurred in 92% of patients, and of these 26 patients, 25 patients had grade 1 or 2 CRS, and only 1 patient developed grade 3 CRS
.

Grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 2 patients and no grade ≥2 ICANS occurred
.

The overall response rate (ORR) was 92.
6%, of which the complete response (CR) rate was 85.
2%, and the median time to response was 1 month
.

After a median follow-up of 7 months, 74.
1% of patients maintained CR, and the 6-month progression-free survival rate was 83.
2%
.

Sibman will continue to follow up and evaluate patients long-term
.

 As early as June 2021, C-CAR039 has been granted orphan drug designation (ODD) by the US FDA for the treatment of follicular lymphoma
.

On December 10, 2021, the FDA officially approved the IND application for C-CAR039
.

 Written by | Mu Zijiu Typesetting | Mu Zijiu End Reference: [1] CBMG Receives FDA Regenerative Medicine Advanced Therapy and Fast Track Designations.
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