This phase I trial studies the side effects of laboratory-treated T cells in treating patients with B-cell chronic lymphocytic leukemia, B-cell lymphoma, or multiple myeloma that has come back or has not gone away after treatment. This study combines two different ways of fighting disease, antibodies (proteins that protect the body from bacterial and other diseases) and T cells (special infection-fighting blood cells that can kill other cells, including cancer cells). Treating the T cells in the laboratory by adding an antibody may help the T cells last longer in the body and kill more cancer cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00881920.
Locations matching your search criteria
United States
Texas
Houston
Texas Children's HospitalStatus: Active
Contact: Carlos Almeida Ramos
Phone: 832-824-4817
Center for Cell and Gene TherapyStatus: Active
Contact: Carlos Almeida Ramos
Phone: 832-824-4817
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterStatus: Active
Contact: Carlos Almeida Ramos
Phone: 832-824-4817
PRIMARY OBJECTIVES:
I. To evaluate the safety of autologous T-lymphocytes genetically modified to express chimeric antigen receptors (CAR) targeting the kappa-light chain of human immunoglobulin (CAR-K) in patients with chronic lymphocytic leukemia (B-CLL), B-cell non-Hodgkin Lymphoma (B-NHL) or other B-cell neoplasm, and multiple myeloma (MM) whose tumors express the Kappa-light chain.
SECONDARY OBJECTIVES:
I. To measure the survival and function of CAR-K+ T cells in vivo.
II. To evaluate the impact of T cell infusions on B lymphocyte compartment and humoral immunity.
III. To measure the anti-tumor effects of CAR-K+ T lymphocytes.
OUTLINE: This is a dose-escalation study.
Patients receive autologous CAR-kappa T-cells intravenously (IV) over 1-10 minutes at least 4 days after finishing their current course of chemotherapy or 14-60 days after date of transplant. At the discretion of the attending physician, patients achieving clinical benefit may receive repeat infusions separated by 4-6 weeks. Some patients may also receive cyclophosphamide IV 4-7 days prior to T cell infusion.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 4 years, and then annually for 10 years.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorCarlos Almeida Ramos