This phase I trial studies the side effects and best dose of NY-ESO-1/MAGE-A4/PRAME/survivin/SSX-specific autologous cytotoxic T lymphocytes (tumor-associated antigen [TAA]-specific cytotoxic T-lymphocytes), and to see how well they work in treating participants with multiple myeloma. TAAs are cell proteins that are specific to cancer cells. TAA-specific cytotoxic T-lymphocytes are special immune system cells made in the laboratory that target five common TAAs called NY-ESO-1, MAGEA4, PRAME, survivin and SSX, which may help destroy the cancer cells in participants with multiple myeloma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02291848.
Locations matching your search criteria
United States
Texas
Houston
Ben Taub General HospitalStatus: Active
Contact: Premal Lulla
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterStatus: Active
Contact: Premal Lulla
Phone: 713-441-1450
Center for Cell and Gene TherapyStatus: Active
Contact: Premal Lulla
Phone: 713-441-1450
PRIMARY OBJECTIVES:
I. To determine the safety of 2 intravenous injections of autologous tumor associated antigen (TAA)-specific cytotoxic T-lymphocytes (CTL) in patients with myeloma.
II. To obtain information on the expansion, persistence and anti-tumor effects of the adoptively-transferred TAA-specific CTL in patients with myeloma
III. To determine whether CTL infusions increase the spectrum of epitopes/antigens targeted by endogenous T cells (epitope spreading).
OUTLINE: This is a dose escalation study.
Participants receive TAA-specific CTL intravenously (IV) over 1-10 minutes on days 0 and 14. Following the 8-week evaluation, eligible participants may receive TAA-specific CTL IV once a month for up to 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 2-week intervals for the first 8 weeks, 3, 6, 9, and 12 months, and then once a year for up to 4 years.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorPremal Lulla