Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CS1-Targeting, Hinge-Optimized, 41BB-Costimulatory Chimeric Antigen Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in Adult Patients With CS1+ Multiple Myeloma
City of Hope Medical Center
Summary
This phase I trial studies the side effects and best dose of CS1-chimeric antigen receptor (CAR) T therapy after chemotherapy in treating patients who have CS1 positive multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Immune cells can be engineered to kill multiple myeloma cells by inserting a piece of deoxyribonucleic acid (DNA) into the immune cells using a lentiviral vector such as CS1, that allows them to recognize multiple myeloma cells. These engineered immune cells, CS1-CAR T cells, may kill multiple myeloma cells.
Description
PRIMARY OBJECTIVE: I. To evaluate the safety and tolerability of intravenous (i.v.) delivered autologous CS1-CAR T cells for research participants with CS1+ recurrent/refractory multiple myeloma (MM). SECONDARY OBJECTIVES: I. Evaluate the response rates at days 28, 100, and 180 post CAR T cell infusion. II. Measure the persistence of CS1-CAR T cells in blood and marrow. III. Measure phenotype and anti-tumor functionality of CS1-CAR T cells in marrow and blood. IV. Measure the levels of cytokines in blood and marrow, and soluble CS-1 in blood post infusion as a surrogate indicator of CAR T…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative. * Assent, when appropriate, will be obtained per institutional guidelines. * Karnofsky Performance Status (KPS) of \>= 70%. * Life expectancy \>= 16 weeks. * Participant must have a confirmed diagnosis of active MM as defined by the International Myeloma Working Group (IMWG) criteria. * Participant must have a confirmed CS1+ MM as evaluated by City of Hope (COH) Pathology Core. * Participant must have measurable disease defined as meeting at least one of the criteria below: * S…
Interventions
- ProcedureCS1-CAR T Therapy
Undergo CS1-CAR T therapy
- DrugCyclophosphamide
Given IV
- DrugFludarabine
Given IV
- ProcedureLeukapheresis
Undergo leukapheresis
Location
- City of Hope Medical CenterDuarte, California