NCT04173988

Study of alloCART-19 Cell Therapy in Pediatric Patients With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

A Single Center, Open Label, Single Arm Exploratory Clinical Study of CD19-Directed Allogeneic Chimeric Antigen Receptor CART-cell Immunotherapy Cell Therapy in Pediatric Patients With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of CD19-Directed Allogeneic Chimeric Antigen Receptor T- cell (alloCART-19)therapy in pediatric patients with relapsed/refractory acute lymphoblastic leukemia（ALL）.

Detailed description

This is a single center, open label, single arm, dose escalation study to explore the safety, tolerability, and pharmacokinetic / pharmacodynamic profile of CD19-Directed Allogeneic Chimeric Antigen Receptor T- cell (alloCART-19) in pediatric patients with relapsed or refractory B-cell acute lymphoblastic leukemia. The study will also assess the preliminary efficacy of CD19-Directed Allogeneic Chimeric Antigen Receptor T- cell (alloCART-19). For this exploratory clinical trial, approximately 3-6 patients will be enrolled. During dose escalation, at least one evaluable patient will be enrolled at each dose level. Once DLT is reached, 1 to 3 additional patients will be enrolled at the dose level below DLT, which has been tested and determined to be safe in the trial, to evaluate the optimal safe and therapeutic dose to be approved by the investigator and sponsor.

Conditions

• ALL, Childhood B-Cell

Interventions

Type	Name	Description
GENETIC	alloCART-19	AlloCART-19 is an allogeneic CAR-T cell product targeting CD19. * For children with body weight ≤ 50 kg, dose range for dose escalation will be 0.5 - 5 × 10\^6 CAR+ cells/kg * For children with body weight \> 50 kg, dose range for dose escalation will be 0.25 - 2.5 × 10\^8 CAR+ cells.
DRUG	Cyclophosphamide	Chemotherapy for lymphodepletion
DRUG	Fludarabine	Chemotherapy for lymphodepletion

Timeline

• Start date: 2020-01-09
• Primary completion: 2024-10-20
• Completion: 2025-07-20
• First posted: 2019-11-22
• Last updated: 2024-03-15

Locations

1 site across 1 country: China