RecruitingEarly Phase 1NCT06730256

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

The First Affiliated Hospital of Soochow University

Enrollment

24 participants

Start Date

Jul 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy called CT0596 in patients with relapsed or refractory multiple myeloma (a blood cancer that has come back or stopped responding to treatment) or plasma cell leukemia. CAR-T therapy involves engineering a patient's own immune cells to attack cancer. **You may be eligible if...** - You are 18 or older - You have relapsed or refractory multiple myeloma and have already received at least 3 prior treatment regimens (including a proteasome inhibitor and an immunomodulatory drug), OR you have plasma cell leukemia that has received at least 1 prior treatment - Your disease is measurable and has progressed during or after your most recent treatment - You are in good general health (ECOG 0-1) - You are willing to use contraception for 1 year after treatment and have no plans for sperm/egg donation during that period **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have HIV, active hepatitis B or C, or active tuberculosis - You have uncontrolled infection or significant unresolved side effects from prior treatment - You received an allogeneic (donor) stem cell transplant, or an autologous transplant within the past 12 weeks - You have active autoimmune disease, certain heart conditions, or severe lung problems - You have another active cancer - You have active brain involvement from the disease 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

CAR-T cells Infusion chimeric antigen receptor T cells


Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT06730256


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