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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Determine the safety and feasibility of administering T cells expressing a novel fully-human anti-CD19 and anti-CD20 CAR construct to patients with advanced B-cell malignancies.
Timeframe: From time of lymphodepleting regimen through 30 days after the last CAR T infusion.