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New treatment option for Advanced Melanoma
Official title NY-ESO-1-redirected T Cells in Patients With Advanced Melanoma and Sarcoma
ClinicalTrials.gov ID: NCT06889766
What this study is testing
What is NY-ESO-1 TCR redirected autologous T cell product?
NY-ESO-1 TCR redirected autologous T cell product is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for advanced melanoma.
Also referred to as LauT-1.
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 single center, dose escalaion, Phase I clinical trial to demonstrate safety and efficacy of LauT-1, autologous "New York Esophageal Squamous Cell Carcinoma-1 T-Cell Receptor (NY-ESO-1 TCR)-directed T cells in combination with non-myeloablative (NMA) lymphodepleting chemotherapy and low dose irradiation (LDI) in patients with NY-ESO-1 positive sarcoma and melanoma.
- 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 18 and older
You may be able to join if
- at pre-screening 1) Patients with histologically confirmed advanced or metastatic cutaneous melanoma or any type of sarcoma. at screening
- Patients with sarcoma, who have received at least one line of standard therapy (if available) and failed to respond, progressed or were intolerant to...
- Patients with metastatic melanoma:
- Without proto-oncogene B-Raf (BRAF) mutation who have received at least one line of standard therapy and failed to respond, progressed or were...
- With BRAF mutation who have received at least two lines of standard therapy and failed to respond, progressed or were intolerant to that therapy...
You likely can't join if
- Patients with an active second malignancy
- Patients with symptomatic and/or untreated brain metastases, as well as leptomeningeal carcinomatosis. Patients with definitively treated brain...
- History of idiopathic pulmonary fibrosis or evidence of active pneumonitis (any origin). History of radiation pneumonitis in the radiation field...
- History of recent myocardial infarction, or unstable angina, within six months prior to enrolment
- Patients with prior allogeneic stem cell transplantation or organ transplantation
- Active severe systemic infections within 2 weeks prior to apheresis
See the full eligibility criteria
- at pre-screening 1) Patients with histologically confirmed advanced or metastatic cutaneous melanoma or any type of sarcoma. at screening
- Patients with sarcoma, who have received at least one line of standard therapy (if available) and failed to respond, progressed or were intolerant to that therapy, will be eligible. If the participant refuses or is, in...
- Patients with metastatic melanoma:
- Without proto-oncogene B-Raf (BRAF) mutation who have received at least one line of standard therapy and failed to respond, progressed or were intolerant to that therapy, will be eligible. If the participant refuses or...
- With BRAF mutation who have received at least two lines of standard therapy and failed to respond, progressed or were intolerant to that therapy, will be eligible. If the participant refuses or is, in the opinion of the...
- Patient must have immunohistochemically documented NY-ESO-1 expression, defined as ≥ 1+ expression on either archival or fresh tumor tissue by immunohistochemistry, in ≥50% of the sampled tumor tissue AND HLA-A\ 0201...
- Age ≥ 18 years
- Able to undergo apheresis
- At least one lesion accessible to biopsy for translational research (TR) at D30, without putting the patient at unusual risk.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Life expectancy of greater than 12 weeks.
- Radiologically measurable disease (as per RECIST v1.1).
- Adequate organ function
- Patients with an active second malignancy
- Patients with symptomatic and/or untreated brain metastases, as well as leptomeningeal carcinomatosis. Patients with definitively treated brain metastases will be considered for enrolment after agreement with the...
- History of idiopathic pulmonary fibrosis or evidence of active pneumonitis (any origin). History of radiation pneumonitis in the radiation field (fibrosis) is allowed.
- History of recent myocardial infarction, or unstable angina, within six months prior to enrolment
- Patients with prior allogeneic stem cell transplantation or organ transplantation
- Active severe systemic infections within 2 weeks prior to apheresis
- Patient requiring regular systemic immunosuppressive therapy. All immunosuppressive medications including but not limited to steroids, mycophenolate mofetil, azathioprine, methotrexate, thalidomide, and anti-Tumor...
- History of severe immediate hypersensitivity reaction to any of the agents/ excipients of the study products.
- Women who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
- people, for whom there are concerns that they will not reliably comply with the requirements for contraception, should not be enrolled into the study.
- Any serious underlying medical condition that could interfere with study medication and potential adverse events.
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Canton of Vaud, Switzerland
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Canton of Vaud, Switzerland. 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.