At a glance
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T Cells Expressing a Fully-Human Anti-CD19 Chimeric Antigen Receptor for Treating B-cell Malignancies
In Brief
A Phase 1 clinical trial evaluating Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells, Cyclophosphamide, and 1 other intervention for Lymphoma, B-Cell and Lymphoma, Non-hodgkins. Completed, enrolled 27 participants across 1 site.
Detailed Summary
Background: The immune system fights infection and can affect cancer cells. T cells are white blood cells that are a major part of the immune system. T cells can destroy tumors. Researchers want to try to manipulate the immune system to better recognize and kill tumor cells. Objective: To test the safety of giving T cells expressing a novel fully-human anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) to people with advanced B-cell cancer. Eligibility: People ages 18-73 with a B-cell cancer that has not been controlled by other therapies. Design: Participants will be screened with: Physical exam Blood and urine tests Heart tests Bone marrow sample taken Scans in machines that take pictures Participants will have apheresis. Blood is removed through a needle in an arm. T cells are removed. The rest of the blood is returned through a needle in the other arm. The cells will be changed in a laboratory. Participants will get 2 chemotherapy drugs over 3 days. Two days later, participants will check into the hospital. They will get an intravenous (IV) catheter in an arm or chest vein. They will get the T cells through the IV in 1 infusion. After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor. Participants will have visits 6 visits for 1 year after the infusion. Some may have more follow-up visits. Participants may samples taken of spinal fluid, bone marrow, and tumors. ...
Study Details
Timeline
Interventions
Dose-escalation trial starting dose: 0.66x10\^6 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10\^6 CAR+ T cells/kg) infuse on day 0
300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3
30 mg/m\^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3