NCT03277729

A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to find the best dose of genetically modified T-cells, to study the safety of this treatment, and to see how well it works in treating patients with B cell non-Hodgkin lymphoma that has come back (relapsed) or did not respond to previous treatment (refractory).

Detailed description

OUTLINE: This is a phase I/II dose-escalation study of CD20-specific CAR T cell therapy. Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide intravenously (IV). Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Patients will be actively participating in the study for approximately 15 months. The total time includes the time for the T cells to be made, the T cell infusion, and for approximately 12 months after the T cell infusion is given. After completion of study treatment, patients are followed up for a minimum of 15 years.

Conditions

• Recurrent B-Cell Non-Hodgkin Lymphoma
• Recurrent Chronic Lymphocytic Leukemia
• Recurrent Diffuse Large B-Cell Lymphoma
• Recurrent Follicular Lymphoma
• Recurrent Lymphoplasmacytic Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Marginal Zone Lymphoma
• Refractory B-Cell Non-Hodgkin Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma
• Refractory Follicular Lymphoma
• Refractory Lymphoplasmacytic Lymphoma
• Refractory Mantle Cell Lymphoma
• Refractory Transformed Non-Hodgkin Lymphoma
• Recurrent Transformed B-Cell Non-Hodgkin Lymphoma
• Recurrent Transformed Chronic Lymphocytic Leukemia
• Refractory Marginal Zone Lymphoma
• Refractory Transformed B-Cell Non-Hodgkin Lymphoma
• Refractory Transformed Chronic Lymphocytic Leukemia
• Recurrent Small Lymphocytic Lymphoma
• Refractory Chronic Lymphocytic Leukemia
• Refractory Small Lymphocytic Lymphoma
• Recurrent Central Nervous System Lymphoma
• Refractory Central Nervous System Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Chimeric Antigen Receptor T-Cell Therapy	Given CD20 CAR T cell IV
DRUG	Cyclophosphamide	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Leukapheresis	Undergo leukapheresis
DRUG	Fludarabine Phosphate	Given IV

Timeline

• Start date: 2017-12-05
• Primary completion: 2024-03-29
• Completion: 2039-03-01
• First posted: 2017-09-11
• Last updated: 2026-01-05
• Results posted: 2025-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study