RecruitingEarly Phase 1NCT06718270

a Study of CT0596 in Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Plasma Cell Leukemia

A Clinical Study to Explore the Safety, Efficacy, and Pharmacokinetics of CT0596 CAR-T Cell Injection in Patients With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Plasma Cell Leukemia


Sponsor

Shanghai Changzheng Hospital

Enrollment

24 participants

Start Date

Dec 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-arm, open-label, exploratory dose-escalation and dose-finding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with R/R MM and PCL.RRMM and RRpPCL


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called CT0596 in patients with multiple myeloma (a blood cancer of plasma cells) or plasma cell leukemia that has come back or stopped responding to previous treatments. CAR-T therapy uses your own immune cells, which are genetically engineered in a lab to recognize and kill cancer cells. **You may be eligible if...** - You are 18 years or older - You have relapsed or treatment-resistant multiple myeloma and have already tried at least 3 prior treatment regimens including at least one proteasome inhibitor and one immunomodulator - You have relapsed or treatment-resistant plasma cell leukemia and have tried at least 1 prior treatment - Your cancer has measurable signs of active disease - Your expected survival is at least 12 weeks - You are in good enough physical condition (ECOG score 0-1) **You may NOT be eligible if...** - Your organ function is poor (liver, kidney, heart, or lungs) - You have active uncontrolled infection or autoimmune disease - You are pregnant or unwilling to use contraception for 1 year after treatment 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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Interventions

DRUGCAR-T cells Infusion

chimeric antigen receptor T cells


Locations(1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

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NCT06718270


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