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NCT number NCT03277729
Study type Interventional
Source Fred Hutchinson Cancer Research Center
Contact
Status Recruiting
Phase Phase 1/Phase 2
Start date December 5, 2017
Completion date November 16, 2037

Clinical Trial 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 or did not respond to previous treatment.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To estimate the maximum tolerated dose (MTD) of adoptive cellular immunotherapy using ex vivo transduced and expanded autologous T cells expressing a third (3rd)-generation fully human CD20-specific chimeric antigen receptor (CAR) in patients with relapsed or refractory CD20+ B-cell non-Hodgkin lymphoma (B-NHL).

SECONDARY OBJECTIVES:

I. To evaluate the safety and toxicity associated with CD20 CAR T cell infusions.

II. To evaluate preliminary antitumor activity of adoptively transferred T cells in patients with measurable tumor burden prior to treatment as measured by overall response rate (ORR) and complete remission (CR) rate.

III. To evaluate progression-free survival (PFS) and overall survival (OS) among patients treated with adoptively transferred CD20-specific T cells.

OUTLINE: This is a phase I/II dose-escalation study of CD20-specific CAR T cell therapy.

Patients undergo leukapheresis and may receive low-intensity chemotherapy including lenalidomide or ibrutinib 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.

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.


Study Design


Related Conditions & MeSH terms

  • CD20 Positive
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin
  • 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 Indolent Non-Hodgkin Lymphoma
  • Waldenstrom Macroglobulinemia

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