Anti-CD19 and anti-CD20 bicistronic CAR T- cells(National Cancer Institute)

Background:
About 23,000 people die from B-cell cancers in the US each year. These cancers, often called leukemia or lymphoma, affect a type of white blood cell called B cells. These cancers are difficult to treat, and the therapies used can have bad side effects. Researchers want to try a new type of treatment. This new treatment uses a patient s own immune cells (T cells) that are modified to carry genes (chimeric antigen receptor, or CAR T cells) to kill cancer cells.
Objective:
To test a treatment using CAR T cells in people with B-cell cancers.
Eligibility:
People aged 18 to 75 years with a B-cell cancer that has not been controlled with standard therapies.
Design:
Participants will be screened. They will have:
Blood and urine tests.
A needle will be inserted to draw a sample of tissue from inside the hip bone.
For some patients, a needle will be inserted into their lower back to get a sample of the fluid around their spinal cord.
A tumor biopsy might be needed.
Imaging scans.
Tests of their heart function.
Participants will undergo apheresis: Blood will be drawn from a needle in an arm. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a second needle.
Participants will receive 2 chemotherapy drugs once a day for 3 days.
Participants will be admitted to the hospital for at least 9 days. Their T cells, now modified, will be infused back into their bloodstream through a tube placed in a large vein.
Follow-up visits will continue for 5 years, but patients will need to stay in touch with the CAR treatment team for 15 year.