RecruitingPhase 1NCT06484777

A Clinical Study of SHR-9539 in Patients With Multiple Myeloma

An Open-label, Multi-center Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of SHR-9539 Injection in Patients With Multiple Myeloma

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

138 participants

Start Date

Aug 7, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

This study is a multicenter, open-label, dose-escalation/dose-expansion clinical Phase I trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy profile of SHR-9539 Injection in patients with multiple myeloma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called SHR-9539 in adults with multiple myeloma, a cancer of the plasma cells in the bone marrow. The study is in an early phase and is looking at how safe and effective the drug is. **You may be eligible if...** - You are 18 or older - You have been diagnosed with multiple myeloma - You have a reasonable level of physical functioning (ECOG 0-1) - You have a life expectancy of at least 3 months - You are willing to use effective contraception during and after treatment **You may NOT be eligible if...** - Your myeloma has spread to the central nervous system (brain or spinal cord) - You have been diagnosed with plasma cell leukemia, amyloidosis, or a related condition - You previously had a severe immune reaction (grade 3+) to CAR-T cell therapy or similar treatments - You have other serious illnesses that require treatment alongside this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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