Carteyva (relmacabtagene autoleucel) / JW (Cayman) Therap 
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  • ||||||||||  Carteyva (relmacabtagene autoleucel) / JW (Cayman) Therap, Yescarta (axicabtagene ciloleucel) / Gilead
    Journal, IO biomarker:  CD19 CAR-T treatment shows limited efficacy in r/r DLBCL with double expression and TP53 alterations. (Pubmed Central) -  Sep 2, 2024   
    Our study suggests that r/r DLBCL patients with both DE status and TP53 alterations treated with CAR-T therapy are more likely to have a poorer clinical prognosis. However, CAR-T therapy has the potential to improve the prognosis of patients with only TP53 alterations or DE status to be similar to that of patients without these abnormalities.
  • ||||||||||  Carteyva (relmacabtagene autoleucel) / JW (Cayman) Therap
    Enrollment closed, Trial primary completion date, CAR T-Cell Therapy:  CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Large B-cell Lymphoma (clinicaltrials.gov) -  Aug 21, 2024   
    P2,  N=10, Active, not recruiting, 
    However, CAR-T therapy has the potential to improve the prognosis of patients with only TP53 alterations or DE status to be similar to that of patients without these abnormalities. Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2024 --> Oct 2024
  • ||||||||||  Review, Journal, HEOR, CAR T-Cell Therapy:  Economic Evaluations of CAR-T Cell Therapies for Hematologic and Solid Malignancies: A Systematic Review. (Pubmed Central) -  Aug 4, 2024   
    CAR-T therapies were more expensive and generated more QALYs than comparators, but their cost-effectiveness was uncertain and dependent on patient population, cancer type, and model assumptions. This highlights the need for more nuanced economic evaluations and continued research to better understand the value of CAR-T therapies in diverse patient populations.
  • ||||||||||  Carteyva (relmacabtagene autoleucel) / JW (Cayman) Therap
    Trial primary completion date, CAR T-Cell Therapy:  CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Large B-cell Lymphoma (clinicaltrials.gov) -  Mar 21, 2024   
    P2,  N=10, Recruiting, 
    Patients will be followed up further and more patients will be dosed with higher doses to observe long term safety and efficacy as well as to determine the potential target treatment dose. Trial primary completion date: Dec 2023 --> Apr 2024
  • ||||||||||  Carteyva (relmacabtagene autoleucel) / JW (Cayman) Therap
    Enrollment change:  Phase I Study of JWCAR029 in Subjects With R/R CLL/SLL (clinicaltrials.gov) -  Nov 27, 2023   
    P1,  N=0, Withdrawn, 
    Trial primary completion date: Dec 2023 --> Apr 2024 N=12 --> 0
  • ||||||||||  Carteyva (relmacabtagene autoleucel) / JW (Cayman) Therap
    Enrollment closed, Trial completion date, Trial primary completion date, CAR T-Cell Therapy:  CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma (clinicaltrials.gov) -  Nov 27, 2023   
    P2,  N=59, Active, not recruiting, 
    N=12 --> 0 Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Aug 2028 | Trial primary completion date: Jun 2023 --> Oct 2023
  • ||||||||||  Carteyva (relmacabtagene autoleucel) / JW (Cayman) Therap
    Enrollment closed:  RELIANCE: CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Non-Hodgkins Lymphoma (clinicaltrials.gov) -  Nov 27, 2023   
    P2,  N=82, Active, not recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Aug 2028 | Trial primary completion date: Jun 2023 --> Oct 2023 Recruiting --> Active, not recruiting
  • ||||||||||  Carteyva (relmacabtagene autoleucel) / JW (Cayman) Therap
    Enrollment open:  Relmacabtagene Autoleucel as First-Line Therapy for High-Risk Large B-Cell Lymphoma (clinicaltrials.gov) -  Oct 17, 2023   
    P2,  N=20, Recruiting, 
    In this phase II study, relma-cel continually demonstrated high response rates (best ORR: 78.57%; best CRR: 66.67%) and good tolerability in patients with r/r MCL. Not yet recruiting --> Recruiting
  • ||||||||||  Carteyva (relmacabtagene autoleucel) / JW (Cayman) Therap
    Journal, HEOR, Cost-effectiveness, Cost effectiveness:  Cost-Effectiveness Analysis of Relmacabtagene Autoleucel for Relapsed or Refractory Large B-Cell Lymphoma in China. (Pubmed Central) -  May 20, 2023   
    Price reduction of CAR-T therapies is the main approach for lowering ICERs and ensuring that the drug costs are proportional to patient health benefits. Compared with salvage chemotherapy, treatment with relma-cel for r/r LBCL in patients who have failed at least 2 lines of systemic therapy is within the cost-effective range from the perspective of Chinese healthcare system and represents a good use of healthcare resources.
  • ||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Efficacy and Safety of Relmacabtagene Autoleucel in Adults with Relapsed/Refractory Follicular Lymphoma in China (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_6470;    
    P2
    With 11.7 months of median follow-up, relma-cel demonstrated remarkable clinical responses achieving high rates of CR and OR, and a manageable safety profile in the phase 2 study of CAR T cell therapy in r/r FL. Updated safety and efficacy data with a longer follow-up will be presented.
  • ||||||||||  Epidaza (chidamide) / Chipscreen, Meiji Seika, Eisai, HUYA Bioscience
    Enrollment change, IO biomarker:  Chidamide Bridging for CAR-T Therapy (clinicaltrials.gov) -  Jun 6, 2022   
    P1/2,  N=120, Recruiting, 
    The uncertainty exists, which however may be reduced by a longer follow-up of the RELIANCE trial. N=80 --> 120
  • ||||||||||  Epidaza (chidamide) / Chipscreen, Meiji Seika, Eisai, HUYA Bioscience
    New P1/2 trial, IO biomarker:  Chidamide Bridging for CAR-T Therapy (clinicaltrials.gov) -  May 11, 2022   
    P1/2,  N=80, Recruiting, 
  • ||||||||||  Carteyva (relmacabtagene autoleucel) / JW (Cayman) Therap
    New P1 trial:  Phase I Study of JWCAR029 in Subjects With R/R CLL/SLL (clinicaltrials.gov) -  Mar 2, 2022   
    P1,  N=12, Not yet recruiting, 
  • ||||||||||  Carteyva (relmacabtagene autoleucel) / JW (Cayman) Therap
    Trial completion date, Trial primary completion date, CAR T-Cell Therapy:  RELIANCE: CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Non-Hodgkins Lymphoma (clinicaltrials.gov) -  Jan 22, 2021   
    P2,  N=82, Recruiting, 
    Relma-cel met the primary endpoint analysis and demonstrated a high rate of durable responses and low rate of CAR-T-associated toxicities in patients with r/r LBCL in a multicenter trial supporting regulatory submission in China. Trial completion date: Jan 2022 --> Sep 2024 | Trial primary completion date: Apr 2020 --> Dec 2022
  • ||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma, relmacabtagene autoleucel (JWCAR029) / JW (Cayman) Therap
    [VIRTUAL] Clinical Response of CD19 CAR-T Cells (relmacabtagene autoleucel, relma-cel) in Adults with Heavily-Pre-Treated Relapsed/Refractory （r/r） Large B-Cell Lymphoma in China (Poster Hall (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_962;    
    Patients were randomized to receive either 100×106 (low dose) or 150×106 (high dose) CAR+ T cells as a single infusion following fludarabine 25 mg/m2 & cyclophosphamide 250 mg/m2 daily×3 as lymphodepletion...The rates of CRS, neurotoxicity (NT), death, and the use of tocilizumab/steroids are shown in Table 1...The RELIANCE Trial provided the first demonstration of licensure-quality CAR-T manufacturing and clinical trial data generation in r/r patients originating in China. These results with relma-cel demonstrate similar preliminary response rates and PK profiles while providing the potential for an improved toxicity profile in heavily-pre-treated patients with r/r DLBCL having poor risk features relative to other CD19-specific CAR-Ts approved in the US and EU.
  • ||||||||||  fludarabine / Generic mfg.
    Clinical Response in Relapsed/Refractory (R/R) B-NHL Treated with the CD19-Directed CAR T-Cell Product JWCAR029 (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_4059;    
    P1
    Conclusion Although longer follow-up is needed, the data from 29 evaluable patients in this Phase I trial have demonstrated high response rates and a favorable safety profile of JWCAR029 in relapsed and refractory B-cell non-Hodgkin lymphoma. A Ph II trial that further assess safety and efficacy of JWCAR029 in DLBCL and FL patients has been initiated and is open for enrollment.