zevorcabtagene autoleucel (CT053)

P=N/A, N=200, Not yet recruiting, CARsgen Therapeutics Co., Ltd.

P1/2, N=121, Active, not recruiting, CARsgen Therapeutics Co., Ltd. | Recruiting --> Active, not recruiting

P1/2, N=120, Recruiting, CARsgen Therapeutics Co., Ltd. | Trial primary completion date: Dec 2023 --> Dec 2024

P1/2, N=105, Active, not recruiting, CARsgen Therapeutics Co., Ltd. | Recruiting --> Active, not recruiting | Phase classification: P1b/2 --> P1/2

All subjects received conditioning treatment of cyclophosphamide (300 mg/m2/day ×3 days) and fludarabine (25 mg/m2/ day × 3 days)...Eight subjects received tocilizumab treatment, of whom one subject with grade 2 CRS received both tocilizumab and steroid... These results demonstrate that CT053 at a target dose of 1.0-1.5×108 CAR+ T cells delivers early and deep responses, including MRD negativity in all complete responders, with an acceptable safety profile in subjects with heavily pretreated RRMM. The results from this LUMMICAR-1 study are consistent with the previous IIT phase 1 studies and the ongoing North American LUMMICAR-2 study and support the launch of pivotal LUMMICAR-1 study in China. Updated results will be presented at this conference.

All subjects received a lymphodepletion regimen of cyclophosphamide (500 mg/m2/day ×2 days) and fludarabine (25 mg/m2/ day × 3 days)...Two subjects received tocilizumab, and one subject with grade 2 CRS received both tocilizumab and steroids. One subject experienced grade 2 neurotoxicity with complete resolution within 24 hours upon administration of dexamethasone...The promising results from the ongoing LUMMICAR-2 study are consistent with the previous phase 1 studies and support the launch of a pivotal Phase 2 LUMMICAR-2 study. Updated results will be presented at the conference.

P=N/A, N=18, Active, not recruiting, Kang YU | Recruiting --> Active, not recruiting | N=48 --> 18 | Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Dec 2019 --> Dec 2020