NCT03434769

AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Non Hodgkin Lymphoma

Phase I Clinical Trial of AntiCD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non Hodgkin Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Benjamin Tomlinson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if it is possible to treat your cancer with a new type of T cell-based immunotherapy (therapy that uses your immune system to treat the cancer). T cells are a type of white blood cell that helps the body fight infections. This treatment uses T cells already present within your body that have been modified outside of the body and returned to target your cancer. This type of treatment is sometimes referred to as adoptive cell transfer (ACT). In this study the specific type of cells that will be used is called chimeric antigen receptor T cells (CAR T cells). Another purpose of this study is to learn about the side effects and toxicities related to this treatment.

Detailed description

Primary Objective: To determine the safety of the treatment of relapsed or refractory B cell lymphomas with chimeric antigen receptor T cells targeting cluster of differentiation antigen 19 (CD19) and to find the recommended phase II dose for this cellular therapy Secondary Objectives * To describe the safety profile of the infusion of CAR-T cells targeting CD19. * To describe the toxicities related to infusion of CAR-T cells targeting CD19. * To describe the overall response rate and complete response rate of relapsed B cell malignancies treated with CAR-T cells targeting CD19.

Conditions

• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cyclophosphamide 60mg/Kg on day -6
DRUG	Fludarabine	Fludarabine 25mg/m\^2 IV on days -5 to -3
BIOLOGICAL	CAR-T Cells	Chimeric antigen receptor T cells to be implemented in a "3 + 3" design on day 0 Level -1 (1 x 105 cells/kg) Level 1 \[Starting dose\] (5 x 105 cells/kg) Level 2 (1 x 106 cells/kg) Level 3 (2 x 106 cells/kg)

Timeline

• Start date: 2018-07-09
• Primary completion: 2023-03-01
• Completion: 2036-02-01
• First posted: 2018-02-15
• Last updated: 2026-02-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study