NCT06756321

A Study of CAR T-Cells in Relapsed/Refractory Hematologic Malignancy

An Exploratory Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor T-Cells (CAR T-Cells) in Subjects with Relapsed/Refractory Hematologic Malignancy

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-center, open-label clinical trial of single-dose of CAR T-cells in subjects with relapsed/refractory hematologic malignancy.

Detailed description

The study will enroll subjects with relapsed/refractory hematologic malignancy, including lymphoma and leukemia. Subjects will receive a single infusion of CAR T-cells after screening, PBMC collection, and lymphodepleting chemotherapy. Toxicity will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from the National Cancer Institute. Safety of CAR T-cell therapy will be evaluated through laboratory tests, including 12-lead electrocardiograms, vital sign checks, and physical examination etc. Additionally, blood samples will be collected to study cellular pharmacokinetics and explore the effects of cell therapy on ferritin, C-reactive protein, and relevant cytokines.

Conditions

• Relapsed/refractory Lymphoma
• Relapsed/Refractory Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD19-CAR T-cells, or anti-CD30-CAR T-cells, or anti-CD20/CD30-CAR T-cells	Each subject will be infused with single dose. A classic "3+3" dose escalation will be employed. anti-CD19-CAR T-cells Dose level 1：1x10\^5 CAR T cells/kg, Dose level 2：3x10\^5 CAR T cells/kg, Dose level 3：1x10\^6 CAR T cells/kg anti-CD30-CAR T-cells Dose level 1：3x10\^6 CAR T cells/kg, Dose level 2：6x10\^6 CAR T cells/kg, Dose level 3：1x10\^7 CAR T cells/kg anti-CD20/CD30-CAR T-cells Dose level 1：1x10\^6 CAR T cells/kg, Dose level 2：3x10\^6 CAR T cells/kg, Dose level 3：1x10\^7 CAR T cells/kg
DRUG	Fludarabine	Fludarabine will be given at a dose of 25 mg/m\^2/day intravenously (IV) for 3 days prior to the infusion of CAR T-cells.
DRUG	Cyclophosphamide	Cyclophosphamide will be given at a dose of 250 mg/m\^2/day intravenously (IV) for 3 days prior to the infusion of CAR T-cells.

Timeline

• Start date: 2023-09-18
• Primary completion: 2025-03-18
• Completion: 2026-03-18
• First posted: 2025-01-03
• Last updated: 2025-01-03

Locations

1 site across 1 country: China