Actively Recruiting

Phase 1
Age: 16Years - 80Years
All Genders
NCT06083883

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

Led by M.D. Anderson Cancer Center · Updated on 2026-04-16

44

Participants Needed

1

Research Sites

244 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 16 to 80 years.
  • Diagnosed with synovial sarcoma or myxoid/round cell liposarcoma confirmed by specific chromosomal translocations.
  • Positive for HLA-A02:01, HLA-A02:05, or HLA-A*02:06 and with at least 50% tumor cells expressing NY-ESO-1.
  • Relapsed or refractory to standard treatments and received at least one prior systemic therapy including doxorubicin and/or ifosfamide or trabectedin.
  • Measurable disease according to RECIST v1.1 criteria.
  • At least 2 weeks from last cytotoxic chemotherapy before lymphodepleting chemotherapy.
  • At least 3 months from any prior cell therapy.
  • Eastern Cooperative Oncology Group performance status 0-1.
  • Adequate organ function including kidney, liver, heart, lung, blood counts, and coagulation.
  • Weight of at least 40 kg.
  • Able to provide written informed consent.
  • Willing to use effective birth control during and for 3 months after treatment.
  • Negative pregnancy test for females of childbearing potential.
  • Signed consent for long-term follow-up.
  • Patients with advanced solid tumors who have received at least one prior line of therapy (for dose escalation cohort).
Not Eligible

You will not qualify if you...

  • Presence of grade 2 or higher toxicity from previous cancer treatments.
  • Active infections requiring intravenous antibiotics or not responding to treatment.
  • Known active hepatitis B or C infection.
  • Detectable HIV viral load.
  • Active neurological disorders.
  • Active autoimmune disease within the past 12 months (except low-grade psoriasis or well-controlled thyroid disease).
  • Amyloidosis or POEMS syndrome.
  • Symptomatic or uncontrolled central nervous system involvement.
  • Other malignancies within the past 2 years except certain treated cancers.
  • Serious medical conditions such as advanced heart failure, recent heart attack or stroke, unstable angina, severe aortic stenosis, uncontrolled arrhythmias, congenital long QT syndrome, or prolonged QTc interval.
  • Major surgery less than 4 weeks before starting chemotherapy.
  • Use of other investigational or anticancer agents.
  • Prior treatment with anti-NY-ESO-1 therapy.
  • Systemic steroid therapy exceeding 10 mg prednisone equivalent daily.
  • Recent treatment with antithymocyte globulin or Campath.
  • Immunosuppressive therapy.
  • Live vaccines within 30 days prior to enrollment.
  • Pregnant or breastfeeding females.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

J

John Livingston, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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