Clinical Trial Goal
To find out:
- The highest dose of JCAR017 CAR T cells that is safe to give
- If JCAR017 CAR T cells in combination with ibrutinib is safe and works well to treat CLL or SLL that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have one of the following diseases that has relapsed or is refractory:
- CLL
- SLL
- Do not have untreated cancer in your brain or spinal cord
- Do not have Richter’s transformation
- Have not been treated with gene therapy before
- Have not been treated with alemtuzumab in the last 6 months
- Have not been treated with cladribine in the last 3 months
- Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 3 months
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Ibrutinib is a small molecule inhibitor that blocks BTK in certain cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
There are 2 parts to this trial: Phase 1 and Phase 2. You’ll be in Phase 1 or Phase 2, but not both. Which phase you are in depends on when you start the trial.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
There are 2 parts to this trial: Phase 1 and Phase 2. You’ll be in Phase 1 or Phase 2, but not both. Which phase you are in depends on when you start the trial.
- Phase 1 – The dose of JCAR017 CAR T cells you get will depend on how many patients have already been treated with it and how safe it has been
- Phase 2 – The dose of JCAR017 CAR T cells you get will be the highest dose shown to be safe in Phase 1
You may receive venetoclax to prepare your body for the CAR T cells. You'll then get treatment with JCAR017 CAR T cells. CAR stands for chimeric antigen receptors and T stands for T cells, a type of immune cell. CAR T cells are a new but unproven way to treat some cancers. This treatment helps your own immune system find and destroy cancer cells.
To make CAR T cells, T cells are collected from your blood by apheresis using a needle similar to when you donate blood. The T cells are treated with the special proteins (antigens) called CARs. CARs help T cells find the cancer cells. The CAR T cells are grown in a lab until there are billions of them. Then, they’re given back to you to find and destroy the cancer cells.
Before you get CAR T cells, you’ll get standard chemotherapy (chemo) to remove the normal T cells from your body to make room for the CAR T cells.
If you’re in Phase 1, you’ll get JCAR017 CAR T cells, given as an intravenous (IV) infusion. You might also get ibrutinib, a pill that you take by mouth.
If you’re in Phase 2, you'll get JCAR017 CAR T cells, given as an intravenous (IV) infusion.
To make CAR T cells, T cells are collected from your blood by apheresis using a needle similar to when you donate blood. The T cells are treated with the special proteins (antigens) called CARs. CARs help T cells find the cancer cells. The CAR T cells are grown in a lab until there are billions of them. Then, they’re given back to you to find and destroy the cancer cells.
Before you get CAR T cells, you’ll get standard chemotherapy (chemo) to remove the normal T cells from your body to make room for the CAR T cells.
If you’re in Phase 1, you’ll get JCAR017 CAR T cells, given as an intravenous (IV) infusion. You might also get ibrutinib, a pill that you take by mouth.
If you’re in Phase 2, you'll get JCAR017 CAR T cells, given as an intravenous (IV) infusion.
After you finish treatment, the clinical trial doctors will check your health for 15 years.
The Food and Drug Administration (FDA) has approved ibrutinib to treat CLL and SLL. The FDA has not yet approved JCAR017 CAR T cells.
The Food and Drug Administration (FDA) has approved ibrutinib to treat CLL and SLL. The FDA has not yet approved JCAR017 CAR T cells.
Contacts
BMS Study Connect Contact Center www.BMSStudyConnect.com, 855-907-3286, Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
Locations
Sponsors
lead: Juno Therapeutics, a Subsidiary of Celgene
