trial with title PILOT - B cell non-Hodgkin lymphoma - TRANSCEND-PILOT-017006 - US

Learn more about the PILOT Study, a phase 2 clinical research study for people with B cell non-Hodgkin lymphoma (NHL)


Am I Eligible?

About TRANSCEND-PILOT-017006

This clinical research study is looking for adults 18 years of age and older who have been diagnosed with aggressive B cell non-Hodgkin lymphoma (NHL). The investigational study treatment uses the body’s own immune cells, called T cells, and modifies them into chimeric antigen receptor (CAR) T cells, which for this study, are called JCAR017.

The purpose of the PILOT Study is to evaluate the use of JCAR017 in individuals who have failed one previous line of therapy for aggressive B cell NHL and are not eligible for hematopoietic stem cell transplant (HSCT). Potential participants will be evaluated to determine their eligibility to participate. Each person who qualifies will receive JCAR017, study-related medical exams, and study-related laboratory tests at no cost. Some parts of this research study involve standard medical care. Your medical insurance may be billed for any standard medical care you receive during the study. We recommend that you consult with your insurance company about its payment policy for standard medical care given during participation in a research study.

About B Cell NHL

Relapsed or refractory aggressive B cell NHL is a cancer that occurs in the blood when B cells (a type of immune cell that helps fight infection) grow and multiply too quickly. Typically, B cell NHL is found in the lymph nodes, tonsils, or spleen, which can cause symptoms such as swollen lymph nodes, chills, fatigue, and a feeling of being full after consuming only a small amount of food.

Right now, research is underway on this investigational study treatment to see if it may help treat B cell NHL. If it is determined that you qualify, you may be able to take part in this study.

About the Investigational CAR T Cell Therapy

CAR T cell therapy is a cancer treatment that works with your body’s own immune system to help fight cancer. Through a process called leukapheresis (pronounced loo-ka-fer-ee-ses), some of your white blood cells will be collected from you. You will have blood drawn into a machine that collects some of your T cells (a subset of your white blood cells, which are part of your immune system and attack things like infections and cancer cells). Those T cells are then sent to a laboratory-based manufacturing facility, where they are modified to help your body recognize and attack the cancer cells once the modified cells are infused.

More about Study Participation

Participation in the PILOT Study lasts approximately two years and includes:

• A screening period that will last up to 14 days, during which your eligibility to participate in the PILOT Study will be confirmed. If you are determined to be eligible, your T cells will be removed (through leukapheresis) and the investigational study treatment will be manufactured. This will take approximately four weeks, but timing varies from patient to patient.
• A pretreatment period that will occur up to seven days before the treatment period. During this time, the study doctor will reconfirm that you are eligible for study participation.
• A treatment period, which will last approximately 35 days.
         o You will receive an infusion one time, after which you will be closely monitored for side effects for the next 30 days.
         o During this time, you will receive three days of conditioning chemotherapy followed by an infusion of the investigational study treatment
• A posttreatment period, during which you will visit the study site at least eight times before your participation in the study ends. This period will last 23 months.

After completion of two years of assessments in this study, an optional long-term follow-up study for survival, long-term toxicity, and safety will continue as a separate study for up to 15 years after administration of JCAR017 investigational study treatment.

The investigational study treatment used in the PILOT Study is called JCAR017. This drug is the result of a modification to a participant’s own immune cells (T cells) with a chimeric antigen receptor (CAR). These modified T cells, (CAR T cells) may attack the cancer cells and other cells. JCAR017 is administered once as an infusion during the treatment period. As with any medicine, JCAR017 may have side effects. As an investigational study treatment, not all the side effects may be known at this time. Two of the primary side effects that you will be monitored for include cytokine release syndrome and neurotoxicity.