A Real-World Observational Study: Zevorcabtagene Autoleucel Injection in Patients with Relapsed/Refractory Multiple Myeloma
NCT ID: NCT06659770
Last Updated: 2024-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2024-10-31
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Zevorcabtagene Autoleucel
Zevorcabtagene Autoleucel is a novel fully human BCMA-targeting CAR-T therapy
Eligibility Criteria
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Inclusion Criteria
2. Subjects with refractory/relapsed multiple myeloma who meet product indication criteria and have received commercialized zevor-cel infusion.
3. 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.
18 Years
ALL
No
Sponsors
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CARsgen Therapeutics Co., Ltd.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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CT053-MM-05
Identifier Type: -
Identifier Source: org_study_id
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