A Phase III Study of JCAR017 Immunotherapy Compared to Standard-of-Care Therapy in People with Recurrent or Persistent B-Cell Non-Hodgkin Lymphoma

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Full Title

A Global Randomized Multicenter Phase 3 Trial To Compare The Efficacy And Safety Of JCAR017 To Standard Of Care In Adult Subjects With High-Risk, Transplant-Eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM)

Purpose

The purpose of this study is to assess the effectiveness of a novel immunotherapy for people with B-cell lymphoma that has continued to grow or came back despite prior therapy. The treatment involves removing some of a patient’s immune cells called T cells, genetically modifying and growing them in a laboratory, and then returning them to the patient to find and kill lymphoma cells.

The new modified T cells are called JCAR017 cells and are given back to the patient intravenously (by vein). Patients in this study will be randomly assigned to receive JCAR017 immunotherapy or a standard treatment for their lymphoma.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have B-cell lymphoma that came back or continued to grow despite prior therapy.
  • Patients must be eligible for stem cell transplantation.
  • Patients should recover from the serious side effects of previous therapies before receiving the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients ages 18-75.

For more information about this study and to inquire about eligibility, please contact Dr. Craig Sauter at 212-639-3460.

Protocol

20-007

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators