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New treatment option for Sarcoma, Synovial
Official title Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers
ClinicalTrials.gov ID: NCT05296564
What this study is testing
What is CYCLOPHOSPHAMIDE and FLUDARABIN?
CYCLOPHOSPHAMIDE and FLUDARABIN is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sarcoma, synovial.
Also referred to as CYTOXAN.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Have histologically or cytologically confirmed diagnosis of neoplasia
- Measurable (per RECIST v1.1 criteria) metastatic cancer or locally advanced refractory/recurrent malignancy not amenable to curative treatment...
- The tumor expresses ESO as assessed immunohistochemistry of resected tissue. To this end, archived tumor tissue suitable for analysis must be...
- Patients must have previously either (1) received at least first-line or second-line standard therapy for metastatic disease, if known to be...
- Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with...
You likely can't join if
- Women of child-bearing potential who are pregnant or breastfeeding.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses
- Concurrent systemic steroid therapy, not including replacement therapy or treatment with prednisone up to 10mg daily or its equivalent. Or any other...
- History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.
- people with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within...
See the full eligibility criteria
- Have histologically or cytologically confirmed diagnosis of neoplasia
- Measurable (per RECIST v1.1 criteria) metastatic cancer or locally advanced refractory/recurrent malignancy not amenable to curative treatment. Lesions previously irradiated may be considered measurable only if growth...
- The tumor expresses ESO as assessed immunohistochemistry of resected tissue. To this end, archived tumor tissue suitable for analysis must be available or re-biopsy performed on study. Tissue staining must encompass...
- Patients must have previously either (1) 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...
- Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after...
- More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities...
- Age ≥ 18 years and ≤ 70 years.
- Patient is able to understand and willing to sign a written informed consent.
- Clinical performance status of ECOG 0, 1 or 2.
- HLA-A\ 0201or A\ 0206 positive.
- Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment.
- Women of child-bearing potential must have a negative pregnancy test.
- Serology: Seronegative for HIV antibody, hepatitis B antigen, and hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
- Hematology
- ANC \> 1500/mm3 without the support of filgrastim
- WBC ≥ 3000/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin \> 8.0 g/dL. people may be transfused to reach this cut-off.
- 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
- Women of child-bearing potential who are pregnant or breastfeeding.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses
- Concurrent systemic steroid therapy, not including replacement therapy or treatment with prednisone up to 10mg daily or its equivalent. Or any other form of immunosuppressive therapy within 7 days before the first dose...
- History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.
- people with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 3 months.
- people unable to maintain normal oxygen saturation level in room air.
- people who have had a venous thromboembolic event requiring anticoagulation and who meet any of the following criteria:
- Have been on a stable dose of anticoagulation for \< 1 month (except for acute line insertion induced thrombosis).
- Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days or are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement).
- Has a known additional malignancy within the last 3 years. Exceptions include early stage cancers (carcinoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in...
- LVEF ≤ 40%
- Documented FEV1 ≤ 60% predicted tested in patients with:
- A prolonged history of cigarette smoking (≥ 20 pack-year smoking history, with cessation within the past two years).
- Symptoms of respiratory dysfunction.
- Patients who are at the time of study initiation receiving any other investigational agents.
- Carcinomatosis meningitis or other brain involvement exceeding that allowed above.
- Has received live vaccine within 30 days before the first dose of study intervention. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies...
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.