OncoMatch/Clinical Trials/NCT05296564
Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers
Is NCT05296564 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including HBI 0201-ESO TCRT and CYCLOPHOSPHAMIDE and FLUDARABIN for sarcoma, synovial.
Treatment: CYCLOPHOSPHAMIDE and FLUDARABIN · Cyclophosphamide · HBI 0201-ESO TCRT · Aldesleukin — A Phase I/II Dose Escalation, Safety and Efficacy Study of HBI 0201-ESO TCRT (anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes) Given by Infusion to Patients with NY-ESO-1 -Expressing Metastatic Cancers
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Melanoma
Triple-Negative Breast Cancer
Breast Carcinoma
Tumor Agnostic
Small Cell Lung Cancer
Urothelial Carcinoma
Neuroblastoma
Biomarker criteria
Required: CTAG1B overexpression (IHC >10% of tumor section)
The tumor expresses ESO as assessed immunohistochemistry of resected tissue... Tissue staining must encompass more than 10% of tumor section.
Required: HLA-A A*0201 or A*0206 positive
HLA-A*0201 or A*0206 positive
Disease stage
Required: Stage IV, LOCALLY ADVANCED REFRACTORY/RECURRENT
Metastatic disease required
Measurable (per RECIST v1.1 criteria) metastatic cancer or locally advanced refractory/recurrent malignancy not amenable to curative treatment
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard therapy for metastatic disease — metastatic or adjuvant
received at least first-line or second-line standard therapy for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease), intolerable or have recurred or (2) Recurred within 6 months of adjuvant systemic therapy known to be active also in the metastatic setting
Lab requirements
Blood counts
ANC > 1500/mm3 without the support of filgrastim; WBC ≥ 3000/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin > 8.0 g/dL. Subjects may be transfused to reach this cut-off.
Kidney function
Creatinine clearance ≥40ml/min
Liver function
Serum ALT/AST ≤ 2.5 x ULN; Total bilirubin ≤ 1.5 mg/dL, except in patients with Gilbert's Syndrome, who must have a total bilirubin < 3.0 mg/dL.
Cardiac function
LVEF > 40%
Hematology: ANC > 1500/mm3 without the support of filgrastim; WBC ≥ 3000/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin > 8.0 g/dL. Chemistry: Serum ALT/AST ≤ 2.5 x ULN; Creatinine clearance ≥40ml/min; Total bilirubin ≤ 1.5 mg/dL, except in patients with Gilbert's Syndrome, who must have a total bilirubin < 3.0 mg/dL. INR < 1.5. LVEF ≤ 40% [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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