Phase 1 clinical results of Sibiman's second-generation CAR-T product were announced, with an objective response rate of 96.4%

Recently, the results of a phase 1 study of C-CAR088, a new second-generation CAR-T cell targeting BCMA, in patients with relapsed or refractory multiple myeloma (R/R MM), were published in the Journal for Immunotherapy of Cancer
.
The results showed that among the 28 evaluable patients, C-CAR088 demonstrated high antitumor activity and an ORR (objective response rate) of 96.
4%, making it a promising treatment option
for R/R MM.

▲ Image source: Reference

C-CAR088 is a novel second-generation CAR-T cell targeting BCMA with 4-1BB as the co-stimulatory factor, and its preliminary clinical trial results show good efficacy and safety
.

Long-term efficacy

Among the 28 patients with evaluable efficacy, the ORR was 96.
4% (13 sCR (complete response in strict sense), 3 CR (complete response), and 9 VGPR (very good partial response)), and with dose increase, the CR/sCR rate increased to 71.
4%
in the high-dose group.
The median follow-up time in the medium- to high-dose cohort was 9.
5 months, and the 12-month PFS (progression-free survival) and OS (overall survival) rates were 69.
5% and 94.
4%, respectively, with median PFS, OS, and DOR not achieved
.

security

The median follow-up of 31 treated patients was 9.
4 months, and no dose-limiting toxicity
was observed.
The most common adverse events were hematologic toxicity, including neutropenia (100%), leukopenia (100%), thrombocytopenia (90.
3%), and anaemia (83.
9%), with expected
toxic effects.

Common grade ≥ 3 adverse events were mainly haematologic toxicity
.
Sixteen patients (51.
6%) developed chronic cytopenia, defined as grade ≥ 3 neutropenia or thrombocytopenia
that did not recover 28 days after treatment.
CRS (cytokine release syndrome) developed in 29 patients (93.
5%) with a median time of onset of 6 days and a median duration of 5 days;

Most CRS (26/31, 83.
9%) were grade 1 to 2, 3 (9.
7%) were grade 3, and none were grade
4.
The most common (≥20%) CRS symptoms were fever (29/29, 100%), hypoxemia (8/29, 27.
6%), elevated D-dimer (7/29, 24.
1%), tachycardia (7/29, 24.
1%), hypotension (6/29, 20.
7%), and elevated aminotransferases (6/29, 20.
7%)
.
One patient in the high-dose group developed grade 1 ICANS (immune effector cell-associated neurotoxic syndrome) on the 8th day of treatment for 24 hours and recovered
after glucocorticoid therapy.

▲ Image source: Reference

Overall, C-CAR088 is a promising treatment option for R/R MM, which is a promising treatment option for R/R MM due to its high antitumor activity and good safety profile, but large multicenter clinical trials are warranted to further confirm.