Actively Recruiting
Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers
Led by Hadassah Medical Organization · Updated on 2025-10-02
3
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of neoplasia
- Measurable metastatic or locally advanced refractory cancer by RECIST v1.1 criteria
- Tumor expresses NY-ESO-1 antigen in more than 10% of tumor tissue
- Prior treatment with at least first- or second-line standard therapy for metastatic disease with progression or intolerance, or recurrence within 6 months of adjuvant therapy
- Three or fewer asymptomatic brain metastases less than 1 cm, stable after treatment
- At least four weeks since prior systemic therapy with recovery to grade 1 or less toxicity (excluding alopecia or vitiligo)
- Age between 18 and 70 years
- Able to understand and willing to sign informed consent
- ECOG performance status 0, 1, or 2
- Positive for HLA-A0201 or A0206
- Willing to use birth control during and for four months after treatment
- Negative pregnancy test for women of child-bearing potential
- Seronegative for HIV, hepatitis B antigen, and hepatitis C antibody; if hepatitis C antibody positive, must be HCV RNA negative
- Adequate blood counts: ANC >1500/mm3, WBC ≥3000/mm3, platelets ≥100,000/mm3, hemoglobin >8.0 g/dL
- Adequate chemistry: ALT/AST ≤2.5 x ULN, creatinine clearance ≥40 ml/min, total bilirubin ≤1.5 mg/dL (≤3.0 mg/dL for Gilbert's Syndrome), INR <1.5
You will not qualify if you...
- Pregnant or breastfeeding women of child-bearing potential
- Primary immunodeficiency disorders
- Active systemic infections requiring treatment or major uncontrolled medical illnesses
- Use of systemic steroids above prednisone 10 mg daily or other immunosuppressive therapy within 7 days before treatment start
- History of severe hypersensitivity to cyclophosphamide, fludarabine, or aldesleukin
- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring intervention within 3 months
- Inability to maintain normal oxygen saturation on room air
- Recent venous thromboembolism requiring anticoagulation with unstable dosing or recent significant bleeding
- Additional malignancy within the last 3 years except certain early-stage cancers
- Left ventricular ejection fraction ≤40%
- Forced expiratory volume in 1 second (FEV1) ≤60% predicted in patients with smoking history or respiratory symptoms
- Receiving other investigational agents at study start
- Carcinomatous meningitis or brain involvement exceeding allowed limits
- Receipt of live vaccines within 30 days before study treatment except killed virus influenza vaccines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hadassah Medical Organization
Jerusalem, Israel, 9112001
Actively Recruiting
Research Team
M
Michal Lotem, Prof.
CONTACT
Y
Yafit Halutsi
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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