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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
October 1, 2024
Primary Completion Date
December 31, 2027
Completion Date
December 31, 2027
Last Updated
October 26, 2024
200
ESTIMATED participants
Zevorcabtagene Autoleucel
DRUG
Lead Sponsor
CARsgen Therapeutics Co., Ltd.
NCT04973605
NCT05862012
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06285318