Actively Recruiting
A Phase I/II Dose Escalation, Safety and Efficacy Study of Anti-NY-ESO-1 T Cell Receptor 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a Phase I/II study to assess the safety, dosing, and effectiveness of anti-NY-ESO-1 T cell receptor (TCR)-gene engineered lymphocytes called HBI 0201-ESO TCRT. This treatment targets patients with metastatic cancers that express the NY-ESO-1 protein, including various sarcomas, melanoma, breast, lung, bladder, neuroblastoma, and ovarian cancers. The study aims to find the best tolerated dose and evaluate clinical response rates in this population. The trial has two parts. Part A involves dose escalation with up to 20 patients receiving increasing doses of HBI 0201-ESO TCRT after preparative chemotherapy with cyclophosphamide and fludarabine. Part B is an expansion phase with up to 43 patients treated at the selected safe dose. The HBI 0201-ESO TCRT cells are infused on Day 0, followed by a continuous infusion of aldesleukin for four days or until specific side effects occur. The dose levels of engineered lymphocytes being tested range from 1x10^9 to 1x10^10 cells. Participants will be monitored for treatment-related side effects and tumor response over five years. Assessments include immune monitoring for the persistence of infused cells and evaluation of tumor shrinkage. Safety and tolerability will be closely observed, including adverse events related to the treatment. The study requires patients to have measurable metastatic cancer expressing NY-ESO-1 and to meet specific health and laboratory criteria before enrollment.
CONDITIONS
Brief 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 cancer or locally advanced refractory/recurrent malignancy not suitable for curative treatment
- Tumor expresses NY-ESO-1 protein in more than 10% of tumor section
- Previously received at least first- or second-line standard therapy with progression, intolerance, or recurrence within 6 months of adjuvant therapy
- Up to 3 asymptomatic brain metastases under 1 cm or surgically resected brain metastases allowed
- At least 4 weeks since prior systemic therapy with recovered toxicities (grade 1 or less)
- Age between 18 and 70 years
- Ability to understand and sign informed consent
- ECOG performance status 0, 1, or 2
- Positive for HLA-A0201 or A0206
- Willingness to practice birth control during and 4 months after treatment
- Negative pregnancy test for women of child-bearing potential
- Seronegative for HIV, hepatitis B antigen, and hepatitis C antibody or PCR negative if antibody positive
- Adequate blood counts and organ function within defined laboratory values
You will not qualify if you...
- Pregnant or breastfeeding women
- Primary immunodeficiency disorders
- Active systemic infections or major uncompensated medical illnesses
- Use of systemic steroids beyond specified low-dose or recent immunosuppressive therapy
- History of severe allergic reactions to study drugs
- Recent serious cardiovascular events within 3 months
- Inability to maintain normal oxygen saturation in room air
- Recent venous thromboembolic events with unstable anticoagulation or recent significant bleeding
- Additional malignancy within 3 years except certain early-stage cancers
- Left ventricular ejection fraction 40% or less
- Reduced lung function with significant smoking history or symptoms
- Current participation in other investigational drug trials
- Extensive brain involvement beyond allowed criteria
- Receipt of live vaccines within 30 days prior to study treatment initiation
- Use of live influenza vaccines (intranasal) prohibited, killed virus influenza vaccines allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive lymphodepletion treatment with cyclophosphamide and fludarabine before the infusion of gene engineered lymphocytes.
Daily visits for 3 days
Duration - 5 days
Participants receive an infusion of Anti-NY-ESO-1 TCR gene engineered lymphocytes, followed by continuous infusion of aldesleukin for up to 4 days or until dose limiting toxicity occurs.
1 infusion visit plus up to 4 days of follow-up visits
Duration - Up to 5 years
Participants are monitored for safety, tumor response, and immune cell persistence for up to 5 years after treatment.
Regular follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
Hadassah Medical Organization
Jerusalem, Israel, 9112001
Actively Recruiting
Research Team
M
Michal Lotem, Prof.
Y
Yafit Halutsi
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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