NCT05651178

Human CD19-CD22 Targeted T Cells Injection for Refractory/Relapsed Central Nervous System Leukemia/Lymphoma Patients

A Early Phase 1 Clinical Trial to Evaluate the Safety and Efficacy of Human CD19-CD22 Targeted T Cells Injection for Subjects with Central Nervous System Involvement of Refractory/Relapsed B Cell Malignancies

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Hrain Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of Human CD19-CD22 Targeted T Cells by intravenous and intrathecal administration, and to preliminarily observe the efficacy of the trial drug in patients with central nervous system involvement of refractory/relapsed B cell malignancies.

Detailed description

Subjects with refractory/relapsed central nervous system involvement of B cell malignancies can participate if all eligibility criteria are met. Tests required to determine eligibility including disease assessments, a physical exam, Electrocardiograph, Computed tomography (CT) / Magnetic Resonance Imaging (MRI) / Positron Emission Tomography (PET), Cerebrospinal fluid exam and blood draws. Subjects will receive preconditioning chemotherapy prior to the infusion of Human CD19-CD22 Targeted T Cells Injection. After the infusion, subjects will be followed for adverse events, pharmacokinetic/pharmacodynamics characteristics, efficacy of Human CD19-CD22 Targeted T Cells Injection. Study procedures may be performed while hospitalized.

Conditions

• Central Nervous System Lymphoma

Interventions

Type	Name	Description
DRUG	Human CD19-CD22 Targeted T Cells Injection	Autologous genetically modified anti-CD19/CD22 CAR transduced T cells

Timeline

• Start date: 2022-08-12
• Primary completion: 2024-11-30
• Completion: 2025-08-31
• First posted: 2022-12-14
• Last updated: 2025-01-07

Locations

1 site across 1 country: China