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

CARsgen Therapeutics

Status: Not yet enrolling

Conditions: Relapsed/Refractory Multiple Myeloma

Treatments: Drug: Zevorcabtagene Autoleucel

Study type: Observational

Funder types: Industry

Identifiers

NCT06659770

CT053-MM-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years;
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.

Exclusion criteria

1. There were no specific exclusion criteria for this study。