RecruitingEarly Phase 1NCT06988059

A Study of CT0596 in Plasma Cell Leukemia

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


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

27 participants

Start Date

Jun 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cell therapy called CT0596 for plasma cell leukemia — a rare and aggressive blood cancer. The treatment engineers a patient's own or donor immune cells to target and destroy cancer cells. **You may be eligible if...** - You are 18 or older - You have plasma cell leukemia that has returned or not responded to prior treatment - Your cancer is measurable - Your expected survival is more than 12 weeks - Your ECOG performance score is 0 or 1 (meaning you are generally active) - Your organ function meets minimum requirements - You are willing to commit to long-term follow-up (up to 15 years, as required by regulations) **You may NOT be eligible if...** - You are pregnant or unwilling to use effective contraception - Your organ function does not meet study requirements - You have other conditions that prevent safe participation 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


Locations(1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

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NCT06988059


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