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| Name | Class |
|---|---|
| Miltenyi Biomedicine GmbH | INDUSTRY |
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The purpose of this study is to evaluate the feasibility, safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion in patients with liver metastases (including but not restricted to) of malignant melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous tumor infiltrating lymphocytes (TIL) | Experimental | Autologous TIL administered via hepatic arterial infusion followed by low dose Interleukin-2 after preconditioning chemotherapy with Melphalan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Tumor Infiltrating Lymphocytes | Drug | Administered via hepatic arterial infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | Adverse events are graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | 5 years from start of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Defined by RECIST 1.1 | 2 years from start of chemotherapy |
| Clinical benefit rate (CBR) | Defined by RECIST 1.1 |
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Inclusion Criteria:
Patients 18-75 years of age on the day of signing informed consent.
Patient is willing and able to provide written informed consent and comply with study procedures. Written informed consent must be signed and dated before the start of specific protocol procedures.
Patient must have a histologically/cytologically confirmed diagnosis of:
Measurable disease by computed tomography (CT) per RECIST 1.1 criteria with at least one target lesion identified in the liver and where the distribution pattern of metastasis is predominantly engaging the liver as judged by the investigator.
At least one resectable lesion in the liver (or aggregate of lesions resected) of a minimum size of 0.5 cm in diameter post- resection to generate TILs.
ECOG performance status of 0 - 2.
Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female patients of childbearing potential must be willing to use a highly efficient method of contraception (Pearl index <1), for the course of the study through 120 days after the last dose of study medication.
Male patients with women of childbearing potential partners must agree to use a condom for contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Ny | Department of Oncology, Sahlgrenska University Hospital, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Sahlgrenska University Hospital | Gothenburg | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41850738 | Derived | Nelson A, Riise R, Alsen S, Wong A, Carlson P, Edman S, Holgersson J, Olofsson Bagge R, Johansson I, Sadik M, Edenbrandt L, Nilsson LM, Nilsson JA, Ny L. Phase I trial of locoregional administration of autologous tumor-infiltrating lymphocytes in patients with uveal melanoma and liver metastases (the HAITILS trial). J Immunother Cancer. 2026 Mar 18;14(3):e014401. doi: 10.1136/jitc-2025-014401. |
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dose escalation
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| Melphalan | Drug | Melphalan will be administered once as an intravenous infusion. |
|
| Interleukin-2 | Drug | After TIL infusion, Interleukin-2 will be administered subcutaneously once daily for up to 14 days. |
|
| 18 weeks |
| Progression free survival (PFS) | Evaluation of progression-free survival | 2 years |
| hepatic Progression free survival (hPFS) | Evaluation of hepatic progression-free survival | 2 years |
| Duration of objective response (DOR) | Evaluation of duration of response | 2 years |
| Overall Survival (OS) | Evaluation of overall survival | 5 years |
| Evaluation of feasibility of an automated production of TILs | Defined as the proportion of patients included that receive treatment with the TIL product. | 2 years |
| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008558 | Melphalan |
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
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