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New treatment option for Synovial Sarcoma
Official title Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1
ClinicalTrials.gov ID: NCT06083883
What this study is testing
What is Fludarabine phosphate?
Fludarabine phosphate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for synovial sarcoma.
Also referred to as Fludarabine, Fludara®.
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
- The goal of this clinical research study is to find a recommended dose of donated NK cells that can be given along with chemotherapy to patients with advanced cancers. The safety and effects of this therapy will also be studied.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 80
You may be able to join if
- Patients with all cancer histology, with an HLA-A\ 02:01, HLA-A\ 02:05 or HLA-A\ 02:06 positive and a positive expression of NY-ESO-1 (\>/= 50% tumor...
- Patients with histologically confirmed synovial sarcoma (cohort 1) or myxoid/round cell liposarcoma (cohort 2), with an HLA-A\ 02:01, HLA-A\ 02:05 or...
- Patients must meet disease-specific eligibility criteria (see below).
- Patients must have relapsed or become refractory to standard of care treatment and must have received at least one prior line of systemic therapy...
- Patients must have measurable disease per the RECIST v1.1 at enrollment.
You likely can't join if
- Presence of clinically significant ≥ Grade 2 toxicity from previous anticancer treatment, as determined by the PI.
- Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management or not responding to appropriate therapy. Note...
- Known Active hepatitis B or C.
- Known human immunodeficiency virus with detectable viral load.
- Presence of active neurological disorder(s).
- Active autoimmune disease within 12 months of enrollment (excluding low-grade psoriasis or well-controlled autoimmune thyroid disease).
See the full eligibility criteria
Who can join
- Patients with all cancer histology, with an HLA-A\ 02:01, HLA-A\ 02:05 or HLA-A\ 02:06 positive and a positive expression of NY-ESO-1 (\>/= 50% tumor cells 2+ or 3+ by IHC) in the preenrollment tumor sample, for the...
- Patients with histologically confirmed synovial sarcoma (cohort 1) or myxoid/round cell liposarcoma (cohort 2), with an HLA-A\ 02:01, HLA-A\ 02:05 or HLA-A\ 02:06 positive and a positive expression of NY-ESO-1 (\>/= 50%...
- Patients must meet disease-specific eligibility criteria (see below).
- Patients must have relapsed or become refractory to standard of care treatment and must have received at least one prior line of systemic therapy including either doxorubicin and/or ifosfamide (synovial sarcoma and...
- Patients must have measurable disease per the RECIST v1.1 at enrollment.
- Patients must be at least 2 weeks from last cytotoxic chemotherapy at the time of first administration of lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until...
- Patients must be at least 3 months from any cell therapy for malignancy.
- Eastern Cooperative Oncology Group performance status 0-1 (Appendix A).
- Adequate organ function at screening, as defined by the following:
- Renal: Serum creatinine ≤ 1.5 mg/dL or estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology Collaboration equation) ≥45 ml/min/1.73 m2
- Hepatic: alanine transaminase (ALT)/aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 x ULN if documented liver metastases, total bilirubin ≤ 1.5 mg/dL or ≤ 3.0 mg/dL for patients with Gilbert's...
- Cardiac: Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no symptomatic cardiac disease or history of...
- Pulmonary: No clinically significant pleural effusion (per principal investigator [PI] judgement), and baseline oxygen saturation ≥ 92% on room air,
- Hematological: absolute neutrophil count (ANC) ≥ 1000/mm3, platelet count ≥ 75,000/mm3, and hemoglobin ≥ 8 g/dL
- Coagulation: International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 ULN. Patients on therapeutic doses of anticoagulation medication must have INR and/or aPTT ≤ the upper...
- Able to provide written informed consent.
- Aged 16-80 years.
- Weight ≥40 kg.
- All male and female patients who are able to have children must practice effective birth control while on study therapy and for up to 3 months post completion of study therapy. Acceptable forms of birth control for...
- Negative serum or urine beta human chorionic gonadotropin pregnancy test for females of childbearing potential (defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females) at...
- Signed consent to long-term follow-up on protocol PA17-0483.
- Disease-specific 17. Advanced solid tumors a. Patients with locally advanced and/or metastatic solid tumors may be enrolled in the dose escalation phase. Patients must have received at least one prior line of standard...
What rules you out
- Presence of clinically significant ≥ Grade 2 toxicity from previous anticancer treatment, as determined by the PI.
- Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management or not responding to appropriate therapy. Note: Patients with simple urinary tract infection and uncomplicated...
- Known Active hepatitis B or C.
- Known human immunodeficiency virus with detectable viral load.
- Presence of active neurological disorder(s).
- Active autoimmune disease within 12 months of enrollment (excluding low-grade psoriasis or well-controlled autoimmune thyroid disease).
- Amyloidosis or POEMS syndrome.
- Symptomatic or uncontrolled central nervous system involvement or signs of cord compression. In the case radiation therapy is indicated, the washout must be at least 14 days. Patients with previously treated brain...
- Patients must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, adequately treated (without recurrence post resection or post radiotherapy) carcinoma of the cervix or...
- Presence of any other serious medical condition that may endanger the patient at investigator's discretion, including but not limited to:
- New York Heart Association Class III or IV heart failure
- Myocardial infarction or stroke ≤ 26 weeks prior to NY-ESO-1 TCR/IL-15 NK cell infusion
- Unstable angina within ≤ 13 weeks prior to NY-ESO-1 TCR/IL-15 NK cell infusion unless the underlying disease has been corrected by procedural intervention (e.g., stent, bypass)
- Severe aortic stenosis.
- Uncontrolled arrhythmia, considered per PI evaluation.
- Congenital long QT syndrome.
- Documentation, during the screening process, of a QTc \> 470 milliseconds by Fredericia criteria (QTcF) based on the average of 3 electrocardiograms (ECGs) taken approximately 1 minute apart and all within 10 minutes of...
- Major surgery \< 4 weeks prior to first dose of lymphodepleting chemotherapy.
- Concomitant use of other investigational agents.
- Concomitant use of other anticancer agents.
- Previously received any anti-NY-ESO-1 therapy.
- Patients receiving systemic steroid therapy at time of enrollment, with an exception for topical, ocular, intranasal, and inhaled corticosteroids, or systemic corticosteroids at an equivalent dose ≤ 10 mg of prednisone...
- Received antithymocyte globulin within 14 days or Campath within 28 days of enrollment.
- Patients receiving immunosuppressive therapy.
- Patients who received live vaccines within 30 days prior enrollment.
- Pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 16 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. 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.