NCT06849921

Precise Design of Cell Therapy for Relapsed and Refractory Hematological Tumors

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to evaluate the efficacy and safety of CAR-T cell therapy in patients with relapsed/refractory hematologic malignancies.

Detailed description

This clinical trial aims to evaluate the efficacy and safety of CAR-T cell therapy in patients with relapsed/refractory hematologic malignancies. The primary objective is to determine the maximum tolerated dose (MTD), safety profile, and the overall response rate (ORR) of CAR-T cells in these patients. Secondary objectives include assessing marrow remission rates and minimal residual disease (MRD) clearance at various time points (2 weeks, 1 month, 3 months, 6 months, and 1 year) in patients with bone marrow involvement, as well as evaluating the changes in multiple sites of involvement through PET-CT or PET-MRI before and one year after CAR-T therapy. The study will also track event-free survival (EFS), progression-free survival (PFS), and overall survival (OS) rates at 1, 2, 3, and 5 years post-treatment.

Conditions

• Precise Design of Cell Therapy for Relapsed and Refractory Hematological Tumors
• Hematologic Disease

Interventions

Type	Name	Description
DRUG	Cellular Therapy	This intervention involves the infusion of autologous or allogeneic CAR-T cells into patients with relapsed/refractory hematologic malignancies. CAR-T cells are modified to target specific antigens on the surface of cancerous cells. After the infusion, patients will be monitored for response and safety. Administration: Intravenous infusion. Dosage: The maximum tolerated dose (MTD) will be determined as part of the study, with dose escalation used to identify the optimal and safest dose of CAR-T cells for treatment.

Timeline

• Start date: 2024-11-07
• Primary completion: 2030-12-30
• Completion: 2030-12-30
• First posted: 2025-02-27
• Last updated: 2025-02-27

Locations

1 site across 1 country: China