NCT04693676

A Study of C-CAR039 Treatment in Subjects With r/r NHL Subjects Non-Hodgkin's Lymphoma

A Phase 1 Study Evaluating Safety and Efficacy of C-CAR039 Treatment in Subjects With Relapsed and/or Refractory NHL

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open label, dose escalation, phase I study of C-CAR039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma.

Detailed description

This is a single-arm, open label, "3+3" dose escalation, phase I study to evaluate the safety and preliminary efficacy of C-CAR039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma. 10 patients are planned to be enrolled. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of C-CAR039. Following manufacture of the drug product, subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide prior to C-CAR039 infusion. All subjects who have received C-CAR039 infusion will be followed for up to 24 months.

Conditions

• Non-Hodgkin's B-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Prizloncabtagene Autoleucel	Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously

Timeline

• Start date: 2020-08-03
• Primary completion: 2023-12-31
• Completion: 2024-04-30
• First posted: 2021-01-05
• Last updated: 2023-09-28

Locations

1 site across 1 country: China