Zevorcabtagene Autoleucel
DrugZevorcabtagene Autoleucel is a novel fully human BCMA-targeting CAR-T therapy
NCT Number: NCT06659770
This study is a single-arm, open-label, multicenter, post-marketing, Phase IV, prospective, observational clinical trial to evaluate the efficacy and safety of the post-marketing product zevor-cel as treatment for subjects with R/R MM in the real world.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Primary study endpoints:
Overall Survival Rate (OS Rate) at 24 months after infusion:Survival rate from the start of cell infusion to 24 months after infusion.
Secondary study endpoints:
Incidence and Severity of Treatment-Related Adverse Events (TEAEs) for zevor-cel Incidence and severity of adverse events (AEs) related to study treatment Incidence of serious adverse events (SAEs) related to study treatment
Other efficacy endpoints of zevor-cel:
Overall response rate (ORR):Proportion of subjects with a partial response (PR) or above.
Complete response or stringent complete response rate (CR/sCR) :The proportion of subjects with the best response of CR/sCR.
Duration of Response (DOR):The time from first response to disease progression or death caused by any reasons in subjects with the best response of PR and above.
Progression Free Survival (PFS) Overall survival (OS): The time from the start of cell infusion to death due to any cause.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Zevorcabtagene Autoleucel is a novel fully human BCMA-targeting CAR-T therapy
Time frame: 24 months
Statistical analysis of OS will be performed, survival curves of OS will be plotted, and 1-year and 2-year survival rates will be calculated. The median, 25% quantile, and 75% quantile of OS will be calculated with their 95% confidence intervals.
Contact information is provided by the study sponsor or research team.
CARsgen Therapeutics Co., Ltd.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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