zevorcabtagene autoleucel (CT053) / CARsgen 
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  • ||||||||||  zevorcabtagene autoleucel (CT053) / CARsgen
    Subgroup Analyses of Phase 2 Study: Evaluating the Efficacy of Fully Human BCMA-Targeting CAR T Cells (Zevorcabtagene Autoleucel) in Patients with Relapsed/Refractory Multiple Myeloma (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_5456;    
    P1/2
    Zevorcabtagene autoleucel (zevor?cel) is a fully human, BCMA-targeting autologous CAR T-cell therapy...There was a trend towards favorable outcomes which was seen in patients without high-risk cytogenetics compared to those with high-risk cytogenetics : 18m DOR rate of 66% versus 58%, 18m PFS rate of 69% versus 56% and an estimated 30m OS rate of 85% versus 76%, however, none of these differences were statistically significant. Conclusion The subgroup analyses of the pivotal Phase II stage of LUMMICAR STUDY 1 indicated that the clinical efficacy of zevor?cel is not significantly impacted by baseline characteristics suggesting that even patients with RRMM with poor prognostic factors may benefit from zevor-cel.
  • ||||||||||  zevorcabtagene autoleucel (CT053) / CARsgen
    Review, Journal:  Zevorcabtagene Autoleucel: First Approval. (Pubmed Central) -  Jun 18, 2024   
    Clinical studies of zevorcabtagene autoleucel are underway in Canada and the US. This article summarizes the milestones in the development of zevorcabtagene autoleucel leading to this first approval for relapsed or refractory multiple myeloma.
  • ||||||||||  zevorcabtagene autoleucel (CT053) / CARsgen
    Three-Year Follow-up on Efficacy and Safety Results from Phase 1 Lummicar Study 1 of Zevorcabtagene Autoleucel in Chinese Patients with Relapsed or Refractory Multiple Myeloma (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_6302;    
    P1/2
    Introduction: Phase 1b of LUMMICAR STUDY 1 was conducted in China (NCT03975907) for zevorcabtagene autoleucel (zevor-cel, CT053), a fully human autologous chimeric antigen receptor (CAR) T-cell therapy comprising a B-cell maturation antigen-specific single-chain variable fragment, in patients with relapsed or refractory multiple myeloma (RRMM)... At approximately 3 years of follow-up, heavily pre-treated RRMM patients maintained deep and durable responses after receiving a single infusion of zevor-cel, which showed a well-managed safety profile in the ongoing long-term follow-up.
  • ||||||||||  zevorcabtagene autoleucel (CT053) / CARsgen
    Enrollment open, Trial completion date, Trial primary completion date:  Clinical Trial to Evaluate CT053 in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 1) (clinicaltrials.gov) -  Jan 30, 2023   
    P1/2,  N=114, Recruiting, 
    At approximately 3 years of follow-up, heavily pre-treated RRMM patients maintained deep and durable responses after receiving a single infusion of zevor-cel, which showed a well-managed safety profile in the ongoing long-term follow-up. Active, not recruiting --> Recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Dec 2023
  • ||||||||||  zevorcabtagene autoleucel (CT053) / CARsgen
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  Clinical Study of CAR-BCMA T Cells in Patients With Refractory or Relapsed Multiple Myeloma (clinicaltrials.gov) -  Oct 12, 2020   
    P=N/A,  N=6, Active, not recruiting, 
    CT053 was well tolerated among the subjects. Recruiting --> Active, not recruiting | N=12 --> 6 | Trial completion date: Sep 2020 --> Jul 2023 | Trial primary completion date: Sep 2019 --> Jul 2020
  • ||||||||||  zevorcabtagene autoleucel (CT053) / CARsgen
    Enrollment closed, Trial completion date, Trial primary completion date:  Clinical Study of CAR-BCMA T in Patients With Refractory or Relapsed Multiple Myeloma (clinicaltrials.gov) -  Oct 7, 2020   
    P1,  N=11, Active, not recruiting, 
    Recruiting --> Active, not recruiting | N=12 --> 6 | Trial completion date: Sep 2020 --> Jul 2023 | Trial primary completion date: Sep 2019 --> Jul 2020 Recruiting --> Active, not recruiting | Trial completion date: Aug 2020 --> Jun 2023 | Trial primary completion date: Apr 2019 --> Jun 2020
  • ||||||||||  Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant Tumors (clinicaltrials.gov) -  Oct 7, 2020   
    P=N/A,  N=18, Active, not recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Aug 2020 --> Jun 2023 | Trial primary completion date: Apr 2019 --> Jun 2020 Recruiting --> Active, not recruiting | N=48 --> 18 | Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Dec 2019 --> Dec 2020
  • ||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma
    Phase 1 Trial of the Safety and Efficacy of Fully Human Anti-Bcma CAR T Cells in Relapsed/Refractory Multiple Myeloma (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_6184;    
    P=N/A, P1
    Subjects received one cycle of CT053 CAR-BCMA after fludarabine/cyclophosphamide infusion...All CRS events (3 G1, 12 G2) recovered within 2-8 days; among them 8 received tocilizumab... This study demonstrated that CT053 had an excellent efficacy and a good safety profile in subjects with rrMM.