RecruitingPhase 1NCT06083883

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

44 participants

Start Date

Mar 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new cell therapy called NY-ESO-1 TCR/IL-15 NK cells — natural killer immune cells that have been modified to recognize and attack a protein called NY-ESO-1, which is found in certain soft-tissue sarcomas (cancers of muscle, fat, and connective tissue). **You may be eligible if...** - You are between 16 and 80 years old and weigh at least 40 kg - You have been diagnosed with synovial sarcoma or myxoid/round cell liposarcoma with a confirmed genetic translocation, OR you have another solid tumor with NY-ESO-1 expression (for the dose escalation phase) - Your tumor tests positive for the NY-ESO-1 protein and a specific tissue type marker (HLA-A*02) - Your cancer has returned or progressed after standard treatment including chemotherapy - Your heart, lungs, liver, and kidneys are functioning adequately **You may NOT be eligible if...** - You have significant unresolved side effects from previous cancer treatment - You have active bacterial, viral, or fungal infection requiring IV treatment - You have active hepatitis B, C, or HIV with a detectable viral load - You have an active autoimmune disease (within the past 12 months) - You are pregnant or breastfeeding - You are currently receiving steroids, immunosuppressive drugs, or another anti-cancer treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFludarabine phosphate

Given by IV (vein)

DRUGNY-ESO-1 TCR/IL-15 NK

Given by IV (vein)

DRUGCyclophosphamide

Given by IV (vein)


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06083883


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