Advanced MelanomaPhase 1LauT1NCT06889766
NY-ESO-1-redirected T Cells in Patients With Advanced Melanoma and Sarcoma
A Phase 1 study testing NY-ESO-1 TCR redirected autologous T cell product, Low-dose irradiation and Non-myeloablative lymphodepleting chemotherapy in people with Advanced Melanoma and Melanoma Metastatic, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma, Melanoma Metastatic, Sarcoma
- What is being tested?
- NY-ESO-1 TCR redirected autologous T cell product, Low-dose irradiation and Non-myeloablative lymphodepleting chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 24 Mar 2025to Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Patients with histologically confirmed advanced or metastatic cutaneous melanoma or any type of sarcoma.
- 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 the opinion of the investigator, ineligible for these treatments, the reason must be documented in the medical record.
- 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 is, in the opinion of the investigator, ineligible for these treatments, the reason must be documented in the medical record.
- 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 investigator, ineligible for these treatments, the reason must be documented in the medical record.
- 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 and/or HLA-A*0205 positive, as identified by high-resolution genomic deoxyribonucleic acid (DNA) typing of the HLA-A locus.
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- 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
Who cannot join
- 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 Principal Investigator, as long as lesions are stable, there are no new brain lesions, and the patient does not require chronic corticosteroid treatment.
- 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
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- Patient requiring regular systemic immunosuppressive therapy. All immunosuppressive medications including but not limited to steroids, mycophenolate mofetil, azathioprine, methotrexate, thalidomide, and anti-Tumor Necrosis Factor-alpha (TNF-alpha) agents must have been discontinued at least 2 weeks before apheresis .
- 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.
- Subjects, 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
Bernhard Gentner, MD, +41 79 556 90 20, Bernhard.Gentner@chuv.ch
- Recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
Bernhard Gentner, MD, +41 79 556 90 20, bernhard.gentner@chuv.ch
Virginie Zimmer, Study Coordinator, +41795566947, virginie.zimmer@chuv.ch
About this study
Official title: A Phase I Study Evaluating Safety and Feasibility of Redirected Autologous T Cells Expressing a High Affinity TCR Specific for NY-ESO-1 (LauT-1) in Patients With Advanced Melanoma and Sarcoma
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.
Read the detailed description
In this study, the investigators target the cancer testis antigen NY-ESO-1, which is highly expressed in a subset of sarcoma and melanoma but is largely absent in normal tissues. The affinity enhanced, Human Leukocyte Antigen - A2 (HLA-A2) restricted I53F T-cell receptor (TCR) used in this study is derived from a TCR originally isolated from a melanoma patient and recognizes the 157-165 epitope of the NY-ESO-1 protein with high affinity. The patients' own T-cells will be isolated, then genetically modified to express the I53F NY-ESO-1 TCR and expanded to generate the product "LauT-1", which is reinfused into the patients following lymphodepleting chemotherapy (LDCT) and low dose tumor irradiation (LDTI). LDCT allows maximal expansion of the infused T cells, and LDTI has been shown to inflame the tumor microenvironment in preliminary clinical data from recent studies, which may be useful to enhance T-cell infiltration and provide co-stimulatory signals within the tumor microenvironment, thereby maximising the chance to detect and potentially eliminate NY-ESO-1 expressing tumor cells.
In the current phase I study, the investigators assess the safety, maximum tolerated dose (MTD) and feasibility of adoptive transfer of LauT-1 after LDCT and LDTI in HLA-A*0201 and/or HLA-A*0205 positive patients with advanced melanoma or sarcoma expressing NY-ESO-1. The experimental products are given initially to a group of 3 patients (safety cohort; cohort 1). If safe, the next 6 patients will be enrolled using a rule-based 3-patient cohort dose-escalation design using split-dosing to determine the MTD of LauT-1 (cohorts 2 and 3).
Procedures:
After confirming the expression of the NY-ESO-1 protein in at least 50% of the tumor cells and the presence of a permissive HLA allele during the pre-screeening procedure, patients eligible for the study will be undergo medical screening and registration to the study, followed by leukapheresis for the collection of autologous white blood cells (T lymphocytes) for the production of the gene-modified LauT-1 product. After successful leukapheresis, patients are allowed to receive a bridging therapy at the discretion of the PI/treating physician.
If all conditions are met and LauT-1 production is completed, the patient will start intravenous (IV) non-myeloablative lymphodepleting chemotherapy (LDCT) composed of fludarabine and cyclophosphamide. Both treatments will be started on the same day. Fludarabine will be given for four days, and cyclophosphamide for 2 days. LDTI will be administered as a single dose on Day 0 to all irradiable lesions using tomotherapy.
On D0, patients will receive NY-ESO-1 TCR T cell infusion, intravenously. Supportive care will be given as needed during the whole treatment period, and patients will be discharged according to institutional practice standards once they have achieved hematologic recovery, in the absence of other reasons for hospitalization. Patients will then be followed weekly in the outpatient clinic until the end of the Treatment-Limiting Toxicity (TLT) period. For cohort 1, the TLT period which extends from the first day of lymphodepleting chemotherapy to D30 after LauT-1 infusion. For cohorts 2 and 3, the TLT period extends from the first day of lymphodepleting chemotherapy to D45 after the first LauT-1 infusion, but no less than 30 days after the second LauT-1 infusion (which may extend the 45-day period by 6 days). After the end of treatment visit, patients will be followed at the outpatient clinic by clinical \& laboratory examination, as well as tumor assessment according to study schedule.
- Conditions
- Advanced Melanoma, Melanoma Metastatic, Sarcoma
- Being tested
- NY-ESO-1 TCR redirected autologous T cell product, Low-dose irradiation, Non-myeloablative lymphodepleting chemotherapy
- Keywords
- NY-ESO-1, LauT-1, TCR redirected T cell, metastatic melanoma, Sarcoma, autolog T-cell
- Medical subject headings
- Sarcoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NY-ESO-1 TCR redirected autologous T cell productBiological
Also called LauT-1
Ex vivo expanded autologous CD4+/CD8+ cells expressing the transgenic TCR I53F recognizing NY-ESO-1 peptides presented on tumor cells in the context of HLA-A*02.
Cohort 1: The LauT-1-ACT infusion contains a minimum of 3x10^8 transduced cells (i.e. CD3+vβ13.1+) and a maximum of 1x10^10 total cells.
Cohort 2 : Patients will receive a fixed dose of 3x10^8 transduced LauT-1 cells (i.e. CD3+vβ13.1+) split over 2 administrations.
Cohort 3: Patients will receive a fixed dose of 6x10^8 transduced LauT-1 cells (i.e. CD3+vβ13.1+) split over 2 administrations.
Low-dose irradiationRadiation
1Gy will be administered using tomotherapy (Accuray) to all irradiable lesions, to all cohorts before the (first) LauT-1 infusion.
Non-myeloablative lymphodepleting chemotherapyDrug
Cohort 1: Fludarabine (30 mg/m2 per day, from D-6 to D-3) and cyclophosphamide (2400 mg/ m2 x 2 days, on days -6 and -5) are administered as an IV infusion. The cyclophosphamide dose may be reduced to 1800mg/m2 on days -6 and -5, if the patient has previously been exposed to significant cumulative doses of chemotherapy).
Cohorts 2 and 3: Fludarabine (30 mg/m2 per day, from D-6 to D-3) and cyclophosphamide (900 mg/ m2 x 2 days, on days -6 and -5) are administered as an IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Other | Not described Receives: Biological: NY-ESO-1 TCR redirected autologous T cell product; Radiation: Low-dose irradiation; Drug: Non-myeloablative lymphodepleting chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by the incidence of treatment emergent adverse events
Safety of LauT-1 plus LDI after lymphodepleting chemotherapy will be established by classifying the observed toxicities by the MedDRA system and grading them using the National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE Version 5.0), American Society for Transplantation and Cellular Therapy (ASTCT) Cytokine Release Syndrom (CRS) or European Hematology Association (EHA) / European Society for Blood and Marrow Transplantation (EBMT) consensus grading for immune effector cell-associated hematotoxicity (ICAHT) , as applicable.
Measured: 90 days following (first) LauT-1 infusion
Feasibility as measured by the rates of production failure and drop-outs before infusion
Feasibility of LauT-1 production and administration will be evaluated as the number of patients who receive LauT-1 at the intended dose according to the assigned dose-level, among all registered patients
Measured: From start of LauT-1 production to administration of intended dose (Cohort 1: 3 weeks after start of LauT-1 production; Cohorts 2-3: second administration of LauT-1 - up to 9 weeks of start of LauT-1 production)
Maximum tolerated dose (MTD) for LauT-1 (applies to Cohorts 2 and 3)
Defined as the highest LauT-1 dose where no TLTs are observed in at least 3 treated patients, or a maximum of 1 non-lethal TLT is observed in a minimum of 5 treated patients.
Measured: End of TLT period (which extends from the first day of lymphodepleting chemotherapy to D45 after the first LauT-1 infusion, but no less than 30 days after the second LauT-1 infusion (which may extend the 45-day period by 6 days)
Secondary outcomes (5)
Long term safety as measured by the incidence of TEAE
Evaluated by documenting clinical and laboratory abnormalities, absence of replication-competent lentivirus, absence of abnormal clonal proliferation and organ toxicity using the MedDRA classification and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Measured: 24 months
Objective response rate (ORR)
Evaluated according to Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1), overall and by cohort. ORR is defined as the rate of patients with best overall response objective response (Complete Response (CR) or Partial Response (PR)) within the first 90 days following LauT-1 infusion.
Measured: 90 days for each patient
Disease control rate (DCR)
Evaluated according to RECIST 1.1, overall and by cohort. DCR is defined as the rate of patients with best overall response stable disease (for at least 3 months) or objective response (CR or PR) across all assessment time-points during the period from enrollment to termination of follow-up or progression (if it occurs before the end of follow-up).
Measured: 2 years
Progression-free survival (PFS)
Is evaluated at 6, 12 and 24 months, where PFS is defined as the time from enrolment until objective tumor progression (using RECIST criteria) or death, if not documented progression.
Measured: 24 months
Overall survival (OS)
OS rate is defined as the time from enrolment until death from any cause. If there is no death date, the patient will be censored at the last day the patient was known to be alive.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start24 Mar 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a single center, dose escalation, Phase I, feasibility and safety trial without comparative arms, enrolling up to 9 patients in 3 dose cohorts. The safety run-in cohort (cohort 1) will follow a 3+3 algorithm. The first 3 patients were recruited sequentially and received a target dose of 2x10\^9 total cells (cohort 1), or a minimum of 3x10\^8 NY-ESO-1 I53F transduced T cells (LauT-1). Following Cohort 1 review (1 out of 3 patients developed a TLT) and IDSMB recommendation, the study has been amended to de-escalate LauT1 and cyclophosphamide dose. The next 6 patients will be enrolled using a rule-based 3-patient cohort dose-finding design and will receive split-dosing. Patients in cohort 2 (n=3) will receive a target dose of 3x10\^8 transduced cells split into two infusions and patients in cohort 3 (n=3) will receive a target dose of 6x10\^8 transduced cells split into two infusions following lymphodepleting chemotherapy and LDI.
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernhard Gentner, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889766
- Sponsor's protocol ID
- CHUV-DO-0026-NYESO1-2023
- Acronym
- LauT1
- Status last verified
- May 2026
- First submitted
- 17 Mar 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating Safety and Feasibility of Redirected Autologous T Cells Expressing a High Affinity TCR Specific for NY-ESO-1 (LauT-1) in Patients With Advanced Melanoma and Sarcoma
- ClinicalTrials.gov ID
- NCT06889766
- Acronym / sponsor ID
- LauT1 / CHUV-DO-0026-NYESO1-2023
- Conditions
- Advanced Melanoma, Melanoma Metastatic, Sarcoma
- Keywords
- NY-ESO-1, LauT-1, TCR redirected T cell, metastatic melanoma, Sarcoma, autolog T-cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, the investigators target the cancer testis antigen NY-ESO-1, which is highly expressed in a subset of sarcoma and melanoma but is largely absent in normal tissues. The affinity enhanced, Human Leukocyte Antigen - A2 (HLA-A2) restricted I53F T-cell receptor (TCR) used in this study is derived from a TCR originally isolated from a melanoma patient and recognizes the 157-165 epitope of the NY-ESO-1 protein with high affinity. The patients' own T-cells will be isolated, then genetically modified to express the I53F NY-ESO-1 TCR and expanded to generate the product "LauT-1", which is reinfused into the patients following lymphodepleting chemotherapy (LDCT) and low dose tumor irradiation (LDTI). LDCT allows maximal expansion of the infused T cells, and LDTI has been shown to inflame the tumor microenvironment in preliminary clinical data from recent studies, which may be useful to enhance T-cell infiltration and provide co-stimulatory signals within the tumor microenvironment, thereby maximising the chance to detect and potentially eliminate NY-ESO-1 expressing tumor cells.
In the current phase I study, the investigators assess the safety, maximum tolerated dose (MTD) and feasibility of adoptive transfer of LauT-1 after LDCT and LDTI in HLA-A*0201 and/or HLA-A*0205 positive patients with advanced melanoma or sarcoma expressing NY-ESO-1. The experimental products are given initially to a group of 3 patients (safety cohort; cohort 1). If safe, the next 6 patients will be enrolled using a rule-based 3-patient cohort dose-escalation design using split-dosing to determine the MTD of LauT-1 (cohorts 2 and 3).
Procedures:
After confirming the expression of the NY-ESO-1 protein in at least 50% of the tumor cells and the presence of a permissive HLA allele during the pre-screeening procedure, patients eligible for the study will be undergo medical screening and registration to the study, followed by leukapheresis for the collection of autologous white blood cells (T lymphocytes) for the production of the gene-modified LauT-1 product. After successful leukapheresis, patients are allowed to receive a bridging therapy at the discretion of the PI/treating physician.
If all conditions are met and LauT-1 production is completed, the patient will start intravenous (IV) non-myeloablative lymphodepleting chemotherapy (LDCT) composed of fludarabine and cyclophosphamide. Both treatments will be started on the same day. Fludarabine will be given for four days, and cyclophosphamide for 2 days. LDTI will be administered as a single dose on Day 0 to all irradiable lesions using tomotherapy.
On D0, patients will receive NY-ESO-1 TCR T cell infusion, intravenously. Supportive care will be given as needed during the whole treatment period, and patients will be discharged according to institutional practice standards once they have achieved hematologic recovery, in the absence of other reasons for hospitalization. Patients will then be followed weekly in the outpatient clinic until the end of the Treatment-Limiting Toxicity (TLT) period. For cohort 1, the TLT period which extends from the first day of lymphodepleting chemotherapy to D30 after LauT-1 infusion. For cohorts 2 and 3, the TLT period extends from the first day of lymphodepleting chemotherapy to D45 after the first LauT-1 infusion, but no less than 30 days after the second LauT-1 infusion (which may extend the 45-day period by 6 days). After the end of treatment visit, patients will be followed at the outpatient clinic by clinical \& laboratory examination, as well as tumor assessment according to study schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single center, dose escalation, Phase I, feasibility and safety trial without comparative arms, enrolling up to 9 patients in 3 dose cohorts. The safety run-in cohort (cohort 1) will follow a 3+3 algorithm. The first 3 patients were recruited sequentially and received a target dose of 2x10^9 total cells (cohort 1), or a minimum of 3x10^8 NY-ESO-1 I53F transduced T cells (LauT-1). Following Cohort 1 review (1 out of 3 patients developed a TLT) and IDSMB recommendation, the study has been amended to de-escalate LauT1 and cyclophosphamide dose. The next 6 patients will be enrolled using a rule-based 3-patient cohort dose-finding design and will receive split-dosing. Patients in cohort 2 (n=3) will receive a target dose of 3x10^8 transduced cells split into two infusions and patients in cohort 3 (n=3) will receive a target dose of 6x10^8 transduced cells split into two infusions following lymphodepleting chemotherapy and LDI.
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Other | Biological: NY-ESO-1 TCR redirected autologous T cell product, Radiation: Low-dose irradiation, Drug: Non-myeloablative lymphodepleting chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1) Patients with histologically confirmed advanced or metastatic cutaneous melanoma or any type of sarcoma.
- 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 the opinion of the investigator, ineligible for these treatments, the reason must be documented in the medical record.
- Patients with metastatic melanoma:
- 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 and/or HLA-A*0205 positive, as identified by high-resolution genomic deoxyribonucleic acid (DNA) typing of the HLA-A locus.
- Age ≥ 18 years
Key exclusion criteria (11 listed)
- 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 Principal Investigator, as long as lesions are stable, there are no new brain lesions, and the patient does not require chronic corticosteroid treatment.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NY-ESO-1 TCR redirected autologous T cell productAlso: LauT-1Ex vivo expanded autologous CD4+/CD8+ cells expressing the transgenic TCR I53F recognizing NY-ESO-1 peptides presented on tumor cells in the context of HLA-A*02. Cohort 1: The LauT-1-ACT infusion contains a minimum of 3x10^8 transduced cells (i.e. CD3+vβ13.1+) and a maximum of 1x10^10 total cells. Cohort 2 : Patients will receive a fixed dose of 3x10^8 transduced LauT-1 cells (i.e. CD3+vβ13.1+) split over 2 administrations. Cohort 3: Patients will receive a fixed dose of 6x10^8 transduced LauT-1 cells (i.e. CD3+vβ13.1+) split over 2 administrations. | Biological | Single arm study |
| Low-dose irradiation1Gy will be administered using tomotherapy (Accuray) to all irradiable lesions, to all cohorts before the (first) LauT-1 infusion. | Radiation | Single arm study |
| Non-myeloablative lymphodepleting chemotherapyCohort 1: Fludarabine (30 mg/m2 per day, from D-6 to D-3) and cyclophosphamide (2400 mg/ m2 x 2 days, on days -6 and -5) are administered as an IV infusion. The cyclophosphamide dose may be reduced to 1800mg/m2 on days -6 and -5, if the patient has previously been exposed to significant cumulative doses of chemotherapy). Cohorts 2 and 3: Fludarabine (30 mg/m2 per day, from D-6 to D-3) and cyclophosphamide (900 mg/ m2 x 2 days, on days -6 and -5) are administered as an IV infusion. | Drug | Single arm study |
Primary outcome
Safety as measured by the incidence of treatment emergent adverse events
Time frame: 90 days following (first) LauT-1 infusion
Safety of LauT-1 plus LDI after lymphodepleting chemotherapy will be established by classifying the observed toxicities by the MedDRA system and grading them using the National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE Version 5.0), American Society for Transplantation and Cellular Therapy (ASTCT) Cytokine Release Syndrom (CRS) or European Hematology Association (EHA) / European Society for Blood and Marrow Transplantation (EBMT) consensus grading for immune effector cell-associated hematotoxicity (ICAHT) , as applicable.
Feasibility as measured by the rates of production failure and drop-outs before infusion
Time frame: From start of LauT-1 production to administration of intended dose (Cohort 1: 3 weeks after start of LauT-1 production; Cohorts 2-3: second administration of LauT-1 - up to 9 weeks of start of LauT-1 production)
Feasibility of LauT-1 production and administration will be evaluated as the number of patients who receive LauT-1 at the intended dose according to the assigned dose-level, among all registered patients
Maximum tolerated dose (MTD) for LauT-1 (applies to Cohorts 2 and 3)
Time frame: End of TLT period (which extends from the first day of lymphodepleting chemotherapy to D45 after the first LauT-1 infusion, but no less than 30 days after the second LauT-1 infusion (which may extend the 45-day period by 6 days)
Defined as the highest LauT-1 dose where no TLTs are observed in at least 3 treated patients, or a maximum of 1 non-lethal TLT is observed in a minimum of 5 treated patients.
5 secondary outcomes
Long term safety as measured by the incidence of TEAE
Time frame: 24 months
Objective response rate (ORR)
Time frame: 90 days for each patient
Disease control rate (DCR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NY-ESO-1 TCR redirected autologous T cell product, Low-dose irradiation and Non-myeloablative lymphodepleting chemotherapy in people with Advanced Melanoma and Melanoma Metastatic, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernhard Gentner, MD (+4179 556 90 20, Bernhard.Gentner@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as measured by the incidence of treatment emergent adverse events (time frame: 90 days following (first) LauT-1 infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.