A Phase I Study of JNJ-67856633 for Patients with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

Full Title

A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-67856633, an Inhibitor of MALT1, in Participants With NHL and CLL

Purpose

The purpose of this study is to find the highest dose of the investigational drug JNJ-67856633 that can be given safely in patients with non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) that has continued to grow despite standard therapy or cannot be treated with standard therapy. JNJ-67856633 works by blocking a protein called MALT 1, which is involved in the growth of cancerous white blood cells. Researchers think that JNJ-67856633 could reverse the effects of MALT1 and slow or stop cancer growth. JNJ-67856633 is taken orally (by mouth).

Eligibility

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

  • Patients must have B-cell NHL or CLL that has come back or continued to grow despite standard treatment or could not be treated with standard therapy.
  • Patients may not have had an autologous (self) stem cell transplant within 3 months of receiving the first dose of JNJ-67856633 or an allogeneic (donated) stem cell transplant within 6 months of the first dose.
  • Patients should recover from the serious side effects of prior treatment 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. Anas Younes at 212-639-7715.

Protocol

19-151

Phase

I

Investigator

Co-Investigators