Phase I/Ib Study of Adoptive NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Reactive Against the NY-ESO-1-specific Cord Blood-derived NK Cells (NY-ESO-1 TCR/IL-15 NK) in Conjunction With Lymphodepleting Chemotherapy for the Management of Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to find a recommended dose of donated NK cells that can be given along with chemotherapy to patients with advanced cancers. The safety and effects of this therapy will also be studied.
Description
Primary Objectives 1. To determine the safety and optimal cell dose of adoptive NK expressing an affinity-enhanced Tcell receptor (TCR) reactive against the NY-ESO-1- r (NY-ESO-1 TCR/IL-15 NK) in patients with advanced synovial sarcoma and myxoid/round cell liposarcoma 2. To determine the antitumor activity of adoptive CB-specific NK cells expressing an affinityenhanced T-cell receptor (TCR) reactive against the NY-ESO-1- (NY-ESO-1 TCR/IL-15 NK). Secondary Objectives 1\. To investigate the correlation between the percentage of NY-ESO-1 in the pre-treatment sample of the tumor, and the tumor…
Eligibility
- Age range
- 16–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with all cancer histology, with an HLA-A\*02:01, HLA-A\*02:05 or HLA-A\*02:06 positive and a positive expression of NY-ESO-1 (\>/= 50% tumor cells 2+ or 3+ by IHC) in the preenrollment tumor sample, for the dose escalation cohort. NY-ESO expression must be confirmed at MDACC prior to study entry. 2. Patients with histologically confirmed synovial sarcoma (cohort 1) or myxoid/round cell liposarcoma (cohort 2), with an HLA-A\*02:01, HLA-A\*02:05 or HLA-A\*02:06 positive and a positive expression of NY-ESO-1 (\>/= 50% tumor cells 2+ or 3+ by IHC) in the pre-enroll…
Interventions
- DrugFludarabine phosphate
Given by IV (vein)
- DrugNY-ESO-1 TCR/IL-15 NK
Given by IV (vein)
- DrugCyclophosphamide
Given by IV (vein)
Location
- MD Anderson Cancer CenterHouston, Texas