NCT05651191

To Evaluate the Safety and Efficacy of Human CD19 Targeted DASH CAR-T Cells Injection for Subjects With R/R B-ALL

A Early Phase 1 Clinical Trial To Evaluate the Safety and Efficacy of Human CD19 Targeted DASH CAR-T Cells Injection for Subjects With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Hrain Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human CD19 targeted DASH CAR-T Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

Detailed description

Subjects with relapsed/refractory B-cell acute lymphoblastic leukemia 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）, and blood draws. Subjects will receive preconditioning chemotherapy prior to the infusion of human CD19 targeted DASH CAR-T Cells injection. After the infusion, subjects will be followed for adverse events, pharmacokinetic/pharmacodynamics characteristics, efficacy of human CD19 targeted DASH CAR-T cells. Study procedures may be performed while hospitalized.

Conditions

• B-cell Acute Lymphoblastic Leukemia

Interventions

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

Timeline

• Start date: 2022-10-21
• Primary completion: 2024-09-30
• Completion: 2025-09-30
• First posted: 2022-12-14
• Last updated: 2022-12-14

Locations

1 site across 1 country: China