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Starting soon Observational

A Real World Study of Equecabtagene Autoleucel in Subjects With Relapsed and Refractory Multiple Myeloma.

NCT06369935 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-06-20
Last updated
2024-04-17

Condition(s) studied

Relapsed/Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

Equecabtagene Autoleucel →

Equecabtagene Autoleucel: Equecabtagene Autoleucel (CT103A) is a novel fully human BCMA-targeting CAR-T therapy

Study summary

This study is a multicenter, observational, single-arm real world study. The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in China with relapsed/refractory multiple myeloma (RRMM) who have been treated with Equecabtagene Autoleucel. This study will use both prospective and retrospective data

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients with confirmed relapsed/refractory multiple myeloma; * Based on clinical practice, the physician decided to administer equecabtagene autoleucel treatment; * Voluntarily sign the informed consent form approved by the ethics committee. Exclusion Criteria: * Patients who are hypersensitive to the active ingredients of the product or any excipients (dimethyl sulfoxide, compound electrolyte injection, human albumin); * The researcher believes that patients are unable to return for follow-up visits or that it is impossible to complete the study; * Patients with expected survival less than 3 months

Primary outcome measure(s)

  • Best Overall Response Rate, BOR — up to 24 weeks
    Patients treatmented with Equecabtagene Autoleucel, the optimal disease state evaluated by the researcher is strict complete response (sCR),complete response (CR), very good partial response (Very Good Partial Response (VGPR) or partial response (partial response,PR) rate.

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06369935 on ClinicalTrials.gov ↗ ← All trials in China