NCT05691153

ThisCART19A for B-NHL Relapsed After Auto-CAR T

A Single-center, Dose Selection Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Allogeneic CAR-T Targeting CD19 in Patients With Auto-CAR T Relapsed B-cell Non-Hodgkin's Lymphoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, single-center, dose selection study to evaluate the efficacy, safety, and pharmacokinetics of ThisCART19A (allogeneic CAR-T targeting CD19) in patients with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma.

Detailed description

This is a phase 1, single-center, dose selection study to evaluate the efficacy, safety, and pharmacokinetics of ThisCART19A in patients with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma. The study will identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile. Before initiating ThisCART19A infusion, subjects will be administered lymphodepletion chemotherapy composed of fludarabine、cyclophosphamide and VP-16. At Day 0 of the Treatment Period, subjects will receive an intravenous (IV) infusion of ThisCART19A. All subjects are monitored during the treatment period through Day 28. All subjects who receive a dose of ThisCART19A will be followed up to 2 years.

Conditions

• CAR
• B Cell Lymphoma
• Relapsed Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	ThisCART19A with Dose Level 1	ThisCART19A，2×10\^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused）, after the lymphodepletion conditioning of fludarabine, CTX and VP-16
DRUG	ThisCART19A with Dose Level 2	ThisCART19A，3×10\^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused）, after the lymphodepletion conditioning of fludarabine, CTX and VP-16

Timeline

• Start date: 2022-12-01
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2023-01-19
• Last updated: 2023-01-19

Locations

1 site across 1 country: China