NCT06083883

Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 response to the treatment. Exploratory Objectives 1. To quantify the persistence of infused allogeneic adoptive NK expressing an affinity-enhanced T-cell receptor (TCR) reactive against the NY-ESO-1-specific CB-derived NK cells (NY-ESO-1 TCR/IL15 NK) in the recipient. 2. To conduct comprehensive immune reconstitution studies. 3. To obtain preliminary data on quality of life and patient experience.

Conditions

• Synovial Sarcoma
• Myxoid/Round Cell Liposarcoma

Interventions

Type	Name	Description
DRUG	Fludarabine phosphate	Given by IV (vein)
DRUG	NY-ESO-1 TCR/IL-15 NK	Given by IV (vein)
DRUG	Cyclophosphamide	Given by IV (vein)

Timeline

• Start date: 2024-03-27
• Primary completion: 2026-11-30
• Completion: 2028-11-30
• First posted: 2023-10-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study