NCT06659770

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: CARsgen Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Relapsed/Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Zevorcabtagene Autoleucel	Zevorcabtagene Autoleucel is a novel fully human BCMA-targeting CAR-T therapy

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-10-26
• Last updated: 2024-10-26