Purpose of this Study
We are doing this study to find out if the study drug JCAR017 is safe and to find out what dose is recommended for patients with relapsed/refractory CLL or SLL.
Who Can Participate?
Eligibility
Adults who:
- Have high risk R/R CLL or SLL who have failed at least 2 prior treatments, including a Bruton Kinase inhibitor (like Ibrutinib)
- Have standard-risk R/R CLL or SLL who have failed at least 3 prior treatments, including a BTK inhibitor like Ibrutinib
What is Involved?
Description
If you choose to join this study, you will:
- Have a screening visit that will include questions, physical exam, ECG, blood work, CT and PET scans, and a bone marrow biopsy
- Have a procedure called leukapheresis which involves removing blood cells from a vein in your arm. These blood cells will be sent to a manufacturing site where they will be used to make the cells that will target your cancer cells
- Come to the clinic for 3 days to get chemotherapy to get your body ready for the infusion of manufactured cells
- Be admitted to the hospital and get the manufactured cells as an infusion into a vein in your arm the next day
- Stay in the hospital for 8 days and then you must come to the clinic for 30 days with a caregiver for tests including questions, physical exam, ECG, blood work, CT and PET scans
- Be in the study for 24-26 months with clinic visits at 2, 3, 6, 9, 12, 18, and 24 months
Study Details
Full Title
An Open-Label, Phase 1/2 Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)
Principal Investigator
Danielle
Brander
Protocol Number
PRO00100726
NCT ID
NCT03331198
Phase
I/II
Enrollment Status
Open to Enrollment