It is important for you to:• Attend all scheduled visits
As a study participant, you will have the right to contact the study’s IRB or EC representative regarding your rights as a research participant. You will also have the right to leave the study at any time for any reason.
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.