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NCT Number: NCT06659770

A Real-World Observational Study: Zevorcabtagene Autoleucel Injection in Patients with Relapsed/Refractory Multiple Myeloma

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years;
  • Subjects with refractory/relapsed multiple myeloma who meet product indication criteria and have received commercialized zevor-cel infusion.
  • Voluntary participation in this study and willingness to sign the informed consent form, for subjects incapable to provide consent, informed consent must be obtained from their legally acceptable guardians.

Exclusion criteria

  • There were no specific exclusion criteria for this study。

Treatment and study plan

Zevorcabtagene Autoleucel

Drug

Zevorcabtagene Autoleucel is a novel fully human BCMA-targeting CAR-T therapy

Primary outcomes

  1. To evaluate long-term survival benefits of zevor-cel in subjects with R/R MM

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenming Chen

CONTACT

[email protected]

13910107759

Sponsors and collaborators

Lead sponsor

CARsgen Therapeutics Co., Ltd.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

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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