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New treatment option for Cutaneous Squamous Cell Carcinoma
Official title TIL Therapy in cSCC and MCC
ClinicalTrials.gov ID: NCT07288073
What this study is testing
What is LN-145?
LN-145 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cutaneous squamous cell carcinoma.
Also referred to as Autologous Tumor Infiltrating Lymphocytes.
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 purpose of this research study is to test the safety and effectiveness of a tumor-infiltrating lymphocyte (TIL) cellular therapy, also called LN-145 or lifileucel, and chemotherapy in combination with Interleukin-2 (IL-2) to find out what effects, if any, the combination has on participants with Cutaneous squamous cell carcinoma (CSCC) or Merkel Cell Carcinoma (MCC) who were previously treated with immunotherapy. The names of the study interventions involved in this study are: Tumor Infiltrating Lymphocytes (a type of cellular therapy) Fludarabine and Cyclophosphamide (types of standard of care chemotherapy drugs) Interleukin-2 (a type of recombinant, human glycoprotein)
- 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 and older
You may be able to join if
- Provide written informed consent, which includes understanding that there may be a need for intensive supportive care measures during the study and...
- Patients must be ≥ than 18 years of age at the time of signing the informed consent form.
- Patients must have histologically or pathologically confirmed diagnosis of CSCC or MCC. Note: Mixed histology is allowed. Note: Neuroendocrine cancer...
- Patients must have unresectable, recurrent, or metastatic disease.
- Patients must have a documented radiographic or clinical disease progression after treatment with ICI (including anti-PD-1 and anti-PD-L1) if it is...
You likely can't join if
- Have a history of allogenic organ transplant.
- Have symptomatic untreated brain metastases. Patients with brain metastases may be enrolled with the following considerations:
- Patients with asymptomatic brain metastases that are treated and have been stable for at least 7 days may be enrolled.
- Patients with historically or recently treated brain metastases will be considered for enrollment if the patient is clinically stable for ≥ 2 weeks...
- Patients who undergo tumor harvest prior to disease progression and develop symptomatic brain metastases after tumor harvest should have receive...
- Require systemic steroid therapy \>10 mg/day prednisone or its equivalent. Patient receiving steroids as replacement therapy for adrenocortical...
See the full eligibility criteria
Who can join
- Provide written informed consent, which includes understanding that there may be a need for intensive supportive care measures during the study and assessing willingness to undergo such measures, and written...
- Patients must be ≥ than 18 years of age at the time of signing the informed consent form.
- Patients must have histologically or pathologically confirmed diagnosis of CSCC or MCC. Note: Mixed histology is allowed. Note: Neuroendocrine cancer that is clinically considered to be related to a cutaneous primary...
- Patients must have unresectable, recurrent, or metastatic disease.
- Patients must have a documented radiographic or clinical disease progression after treatment with ICI (including anti-PD-1 and anti-PD-L1) if it is used in the palliative setting. In patients who received ICI in the...
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 in the investigator's opinion (Appendix B).
- Patients must have at least 1 resectable lesion (or aggregate lesions) with an expected minimum of 1.5 cm diameter in the short axis for TIL production. Note: If a lesion that is considered for TIL harvest is within a...
- Patients must be expected to have at least 1 remaining measurable lesion as defined by RECIST v1.1 or evaluable (radiographically or on clinical examination) following tumor harvest for TIL manufacturing and production...
- Lesions in a previously irradiated areas should not be selected as target lesions unless progression has been demonstrated in those lesions and the irradiation has been completed at least 6 months prior to enrollment.
- Patients who have only one site of disease may be enrolled if they have a lesion th can be partially resected for TIL harvest, and the remaining portion of the lesion is measurable or evaluable.
- Patients must have the following hematologic parameters:
- Absolute neutrophil count (ANC) ≥ 1000/mm3
- Hemoglobin ≥ 8.0 g/dL and have not received transfusion of packed red blood cells within 7 days.
- Platelet count ≥ 100,000/mm3
- Patients must have an adequate organ function with the following laboratory test values:
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); and for patients with liver metastases ≤ to 5 times ULN.
- Total bilirubin ≤ 2 mg/dL; patients with Gilbert's Syndrome ≤ to 3 mg/dL.
- Estimated creatinine clearance (eCrCl) ≥ 40 mL/min using the Cockcroft-Gault formula at Screening.
- Patients must have a left ventricular ejection fraction (LVEF) ≥ 45% and be New York Heart Association (NYHA) Class 1 or 2. A cardiac stress test is required for patients who have significant ischemic heart disease, or...
- Patients must have adequate pulmonary function within 2 months from enrollment. Patients require pulmonary function testing (PFT) if they have any of the following:
- History of cigarette smoking of ≥ 20 pack-years
- Ceased smoking within the past 2 years or still smoking.
- History of chronic obstructive pulmonary disease (COPD)
- Any signs or symptoms of significant respiratory dysfunction. Post-bronchodilator required pulmonary test results:
- Forced expiratory volume (FEV1)/ forced vital capacity (FVC) \> 70%. Or
- FEV1 \> 50% of predicted normal value. Note: If a patient is unable to perform reliable spirometry due to abnormal upper airway anatomy (i.e., tracheostomy), a 6-minute walk test may be used to assess pulmonary...
- Patients must have completed or discontinued systemic therapy ≥ 21 days prior to tumor harvest. Note: Patients are allowed to have palliative radiation or systemic therapy after tumor harvest and before NMA-LD but there...
- Patients must have recovered from all prior anticancer TRAEs to Grade ≤ 1 (per CTCAE v5.0) with the exceptions of vitiligo, alopecia or neuropathy. Patients with irreversible toxicity that are properly managed (such as...
- Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and for 12 months after receiving all...
- Combined (estrogen- and progesterone- containing) hormonal birth control associated with inhibition of ovulation: oral, intravaginal, transdermal.
- Progesterone-only hormonal birth control associated with inhibition of ovulation: oral, injectable, implantable.
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomy
- True absolute sexual abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar ovulation, symptothermal, post-ovulation methods) is not acceptable.
What rules you out
- Have a history of allogenic organ transplant.
- Have symptomatic untreated brain metastases. Patients with brain metastases may be enrolled with the following considerations:
- Patients with asymptomatic brain metastases that are treated and have been stable for at least 7 days may be enrolled.
- Patients with historically or recently treated brain metastases will be considered for enrollment if the patient is clinically stable for ≥ 2 weeks, and the patient does not require ongoing corticosteroid treatment...
- Patients who undergo tumor harvest prior to disease progression and develop symptomatic brain metastases after tumor harvest should have receive appropriate treatment for ≥ 2 weeks and not require corticosteroids (\>10...
- Require systemic steroid therapy \>10 mg/day prednisone or its equivalent. Patient receiving steroids as replacement therapy for adrenocortical insufficiency are not excluded.
- Have evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment.
- Are pregnant or breastfeeding. Female patients of childbearing potential must have a negative beta human chorionic gonadotropin (B-HCG) test at Screening (Appendix C).
- Have active medical illness that in the opinion of the investigator would pose increased risk for study participation, such as systemic infections, coagulation disorders, or other active major medical illnesses of the...
- Have received a live or attenuated vaccination within 28 days prior to the start of NMALD.
- Have any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease [SCID] or acquired immune deficiency syndrome [AIDS]).
- Have a history of allogenic stem cell transplant, or active hematological malignancy (such as chronic lymphocytic leukemia or lymphoma).
- Have a history of hypersensitivity to any component of the study drugs. TIL should not be administered to patients with a known hypersensitivity to any component of the autologous TIL product formulation including, but...
- NMA-LD (cyclophosphamide, mesna, and fludarabine)
- Proleukin, aldesleukin, IL-2
- Antibiotics of the aminoglycoside group. These patients may be eligible if current hypersensitivity has been excluded.
- Any component of the TIL product formulation, including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, or dextran-40
- Have had another primary malignancy within the previous 1 year (except for malignancies that do not require treatment or have been curatively treated, and do not pose a significant risk of recurrence including, but not...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, 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.