NCT06066359

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 patient experience. * Assess duration of response (DOR) Secondary end points * Day +180 PFS rate; * NY-ESO-1 TCR/IL-15 NK cell numbers in peripheral blood vs time profile; * Characterization of lymphocyte populations at various time points; * PROMIS-29 quality of life questionnaire score. * Duration of response

Conditions

• Myeloma

Interventions

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

Timeline

• Start date: 2023-11-30
• Primary completion: 2026-08-31
• Completion: 2028-08-31
• First posted: 2023-10-04
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study