A Phase I Study of BTCT4465A Immunotherapy in Patients with Recurrent or Persistent B-cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

Full Title

An Open-Label, Multicenter, Phase I Trial Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of BTCT4465A In Patients With Relapsed Or Refractory B-Cell Non-Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia

Purpose

The purpose of this study is to find the highest dose of the investigational drug BTCT4465A that can be given safely in patients with B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) that has continued to grow or came back despite prior treatment.

BTCT4465A is a form of immunotherapy. It attaches to cancerous B cells and normal T cells in the immune system. BTCT4465A is designed to trigger an immune response against cancer cells by directing T cells to kill cancerous B cells. It is given intravenously (by vein).

Eligibility

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

  • Patients must have CD20-positive B-cell NHL or CLL that has come back or continued to grow despite prior treatment.
  • Patients must recover from the serious side effects of previous therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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 age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Matthew Matasar at 212-639-8889.

Protocol

16-182

Phase

I/II

Investigator

Co-Investigators

Locations