OncoMatch/Clinical Trials/NCT06083883
Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1
Is NCT06083883 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Fludarabine phosphate and NY-ESO-1 TCR/IL-15 NK for synovial sarcoma.
Treatment: Fludarabine phosphate · NY-ESO-1 TCR/IL-15 NK · Cyclophosphamide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Biomarker criteria
Required: HLA-A A*02:01 positive
HLA-A*02:01 positive
Required: HLA-A A*02:05 positive
HLA-A*02:05 positive
Required: HLA-A A*02:06 positive
HLA-A*02:06 positive
Required: CTAG1B overexpression (>= 50% tumor cells 2+ or 3+ by IHC)
positive expression of NY-ESO-1 (>= 50% tumor cells 2+ or 3+ by IHC) in the preenrollment tumor sample
Required: SS18 fusion with SSX1
translocation between SYT on the X chromosome and SSX1 ... (may be presented in the pathology report as t (X; 18))
Required: SS18 fusion with SSX2
translocation between SYT on the X chromosome and SSX2 ... (may be presented in the pathology report as t (X; 18))
Required: SS18 fusion with SSX4
translocation between SYT on the X chromosome and SSX4 ... (may be presented in the pathology report as t (X; 18))
Required: FUS fusion with DDIT3
reciprocal chromosomal translocation t(12;16)(q13;p11)
Required: EWSR1 fusion with DDIT3
reciprocal chromosomal translocation t(12;22)(q13;q12)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: cytotoxic chemotherapy (doxorubicin, ifosfamide)
at least one prior line of systemic therapy including either doxorubicin and/or ifosfamide (synovial sarcoma and MRCLS)
Must have received: cytotoxic chemotherapy (trabectedin)
at least one prior line of systemic therapy including ... trabectedin (MRCLS)
Cannot have received: anti-NY-ESO-1 therapy
Previously received any anti-NY-ESO-1 therapy
Cannot have received: cell therapy
Exception: must be at least 3 months from any cell therapy for malignancy
Patients must be at least 3 months from any cell therapy for malignancy
Lab requirements
Blood counts
ANC ≥ 1000/mm3, platelet count ≥ 75,000/mm3, hemoglobin ≥ 8 g/dL
Kidney function
Serum creatinine ≤ 1.5 mg/dL or eGFR ≥45 ml/min/1.73 m2
Liver function
ALT/AST ≤ 2.5 x ULN or ≤ 5 x ULN if documented liver metastases, total bilirubin ≤ 1.5 mg/dL or ≤ 3.0 mg/dL for patients with Gilbert's Syndrome. No history of liver cirrhosis and no ascites.
Cardiac function
Ejection fraction ≥ 50%, no clinically significant pericardial effusion, no symptomatic cardiac disease or history of serious ventricular arrhythmia, high-grade AV block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for well-controlled atrial fibrillation)
Adequate organ function at screening, as defined by the following: Renal: Serum creatinine ≤ 1.5 mg/dL or eGFR ≥45 ml/min/1.73 m2; Hepatic: ALT/AST ≤ 2.5 x ULN or ≤ 5 x ULN if documented liver metastases, total bilirubin ≤ 1.5 mg/dL or ≤ 3.0 mg/dL for patients with Gilbert's Syndrome. No history of liver cirrhosis and no ascites; Cardiac: Ejection fraction ≥ 50%, no clinically significant pericardial effusion, no symptomatic cardiac disease or history of serious ventricular arrhythmia, high-grade AV block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for well-controlled atrial fibrillation); Pulmonary: No clinically significant pleural effusion (per PI judgement), and baseline oxygen saturation ≥ 92% on room air; Hematological: ANC ≥ 1000/mm3, platelet count ≥ 75,000/mm3, hemoglobin ≥ 8 g/dL; Coagulation: INR ≤ 1.5 ULN and aPTT ≤ 1.5 ULN. Patients on therapeutic doses of anticoagulation medication must have INR and/or aPTT ≤ the upper limit of the therapeutic range for intended use.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify