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 (Jun 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
Treatments studied
Chemotherapy
Other
Cancer type
Sarcoma
Melanoma
Triple-Negative Breast Cancer
Breast Carcinoma
Tumor Agnostic
Non-Small Cell Lung Carcinoma
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)
Demographics
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.
Frequently asked questions
Is NCT05296564 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received standard therapy for metastatic disease.
Does this trial require CTAG1B?
Yes, CTAG1B overexpression is a required biomarker for enrollment.
Does this trial require HLA-A?
Yes, HLA-A A*0201 or A*0206 positive is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV or LOCALLY ADVANCED REFRACTORY/RECURRENT is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 70 years or younger.
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 qualifyRelated pages