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+ 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-enrollment tumor sample 2. Patients are HLA-A\*02:01positive on HLA typing 3. Patients with relapsed or refractory MM (patients with solitary plasmacytoma are not eligible) who meet the following criteria: 1. \> or = 4 prior lines of therapy (including exposure to at least one proteasome inhibitor, ImiD, and anti-cd38 antibody and bcma targeted agent 2. have measurable disease (serum monoclonal (M) protein level ≥0.5 g/dL, and/or urine M protein level ≥200 mg/day, and…
Interventions
- DrugFludarabine phosphate
Given by (IV) vein
- DrugCyclophosphamide
Given by (IV) vein
- DrugNY-ESO-1 TCR/IL-15 NK
Given by (IV) vein
Location
- M D Anderson Cancer CenterHouston, Texas