Phase I/II Trial of Cord Blood-Derived NK Cells Genetically Engineered With NY-ESO-1 TCR/IL-15 Cell Receptor for Relapsed/Refractory Multiple Myeloma
M.D. Anderson Cancer Center
Summary
To find the recommended dose of NY-ESO-1 TCR/IL-15 NK cells that can be given to patients with relapsed or refractory MM. To learn if the dose of NY-ESO-1 TCR/IL-15 NK cells found in Part A can help to control the disease.
Description
Primary Objectives: * Part A: To assess dose-limiting toxicity (DLT) and determine the safety and optimal cell dose of NY-ESO-1 TCR/IL-15 NK cells in patients with relapsed/refractory multiple myeloma. * Part B: To assess the day +90 overall response rate in patients treated at the optimal cell dose. Secondary Objectives: * Assess day +180 progression-free survival (PFS). * Quantify the persistence of infused allogeneic donor TCR-transduced CB-derived NK cells in the recipient. * To conduct comprehensive immune reconstitution studies. * To obtain preliminary data on quality of life and pati…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: 1\. Patients with multiple myeloma with an expression of NY-ESO-1 by immunohistochemistry in the pre-screening or screening tumor sample or PCR NY-ESO-1 testing by Pathology. CD138 by immunostains will be performed to identify plasma cells before testing for NY-ESO-1 2. Patients are HLA-A\*02:01, HLA-A\*2:05, or HLA-A\*2:06 positive on human leukocyte antigen (HLA) typing at any time. 3\. Patients with relapsed or refractory multiple myeloma (MM) (patients with solitary plasmacytoma are not eligible) who meet the following criteria: 1. \> or = 2 prior lines of therapy (i…
Interventions
- DrugFludarabine phosphate
Given by (IV) vein
- DrugCyclophosphamide
Given by (IV) vein
- DrugAllogeneic Anti-NY-ESO-1-TCR-IL-15-transduced Cord Blood-derived Natural Killer Cells
Given by (IV) vein
Location
- M D Anderson Cancer CenterHouston, Texas