NCT06988059

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. During the trial, dose increases or decreases or dose expansion may be performed using i3+3 principle based on the safety and ,tolerability and PK data of the patients.

Conditions

• Plasma Cell Leukemia

Interventions

Type	Name	Description
DRUG	CAR-T cells Infusion chimeric antigen receptor T cells	CAR-T cells Infusion

Timeline

• Start date: 2025-06-25
• Primary completion: 2027-01-03
• Completion: 2027-12-31
• First posted: 2025-05-23
• Last updated: 2025-08-01

Locations

1 site across 1 country: China