Evidence map›Paper›PMID 41850738›Full record

ArticleJournal for immunotherapy of cancer2026

Phase I trial of locoregional administration of autologous tumor-infiltrating lymphocytes in patients with uveal melanoma and liver metastases (the HAITILS trial).

Axel Nelson, Rebecca Riise, Samuel Alsén, Andrew Wong, Per Carlson, Sebastian Edman, Jan Holgersson, Roger Olofsson Bagge, Iva Johansson, May Sadik and 4 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal for immunotherapy of cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04812470 (A Phase I Study Using Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04812470 phase1completednot on this map

A Phase I Study Using Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases

TypeinterventionalSponsorVastra Gotaland RegionRan2023 to 2025Enrolled8ConditionsMetastatic Uveal Melanoma, Metastatic Cutaneous MelanomaArmsAutologous Tumor Infiltrating Lymphocytes, Melphalan, Interleukin-2
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Axel NelsonDepartment of Oncology, Institute of Clinical Sciences, University of Gothenburg Sahlgrenska Academy, Gothenburg, Sweden.ORCID http://orcid.org/0009-0005-8898-8301
Rebecca RiiseSahlgrenska Center for Cancer Research, Department of Surgery, University of Gothenburg Sahlgrenska Academy, Gothenburg, Sweden.
Samuel AlsénSahlgrenska Center for Cancer Research, Department of Surgery, University of Gothenburg Sahlgrenska Academy, Gothenburg, Sweden.
Andrew WongSahlgrenska Center for Cancer Research, Department of Surgery, University of Gothenburg Sahlgrenska Academy, Gothenburg, Sweden.
Per CarlsonDepartment of Radiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
Sebastian EdmanDepartment of Clinical Immunology and Transfusion Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.
Jan HolgerssonDepartment of Clinical Immunology and Transfusion Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.
Roger Olofsson BaggeSahlgrenska Center for Cancer Research, Department of Surgery, University of Gothenburg Sahlgrenska Academy, Gothenburg, Sweden.ORCID http://orcid.org/0000-0001-5795-0355
Iva JohanssonDepartment of Pathology, Sahlgrenska Academy, Gothenburg, Sweden.
May SadikDepartment of Clinical Physiology, Sahlgrenska Academy, Gothenburg, Sweden.
Lars EdenbrandtDepartment of Clinical Physiology, Sahlgrenska Academy, Gothenburg, Sweden.
Lisa M NilssonSahlgrenska Center for Cancer Research, Department of Surgery, University of Gothenburg Sahlgrenska Academy, Gothenburg, Sweden.ORCID http://orcid.org/0000-0002-5222-7210
Jonas A Nilsson *Sahlgrenska Center for Cancer Research, Department of Surgery, University of Gothenburg Sahlgrenska Academy, Gothenburg, Sweden lars.ny@oncology.gu.se jonas.a.nilsson@surgery.gu.se.ORCID http://orcid.org/0000-0003-0346-6837
Lars Ny *Department of Oncology, Institute of Clinical Sciences, University of Gothenburg Sahlgrenska Academy, Gothenburg, Sweden lars.ny@oncology.gu.se jonas.a.nilsson@surgery.gu.se.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUveal melanoma is a rare melanoma subtype characterized by a liver-dominant pattern of metastasis which is associated with a lack of durable responses to immunotherapies. Adoptive cell transfer of autologous tumor-infiltrating lymphocytes (TILs) has been shown to induce responses in a subset of patients with metastatic uveal melanoma. The safety and feasibility of locoregional administration of TIL therapy via hepatic arterial infusion (HAI) have not previously been evaluated. PATIENTS AND

methodsThis prospective, open-label, phase I trial investigated the safety and feasibility of one-time TIL therapy administered via HAI in patients with liver metastases of uveal melanoma. Preconditioning chemotherapy with melphalan (1 mg/kg, intravenous) was administered on day -5. TILs were delivered via percutaneous catheterization of the hepatic artery according to a dose escalation scheme (0.1, 0.3, or 1×10

resultsSix patients received TIL therapy manufactured using the CliniMACS Prodigy platform; five were treated according to protocol, while one received a lower TIL dose than planned. All had received prior systemic treatment. No AEs related to the HAI procedure were observed. All patients experienced grade ≥3 hematologic AEs related to preconditioning chemotherapy, and two patients experienced grade ≥3 AEs attributed to TIL/IL-2. Best overall response was stable disease in all patients (100%). Median progression-free survival was 4 months, and median overall survival was 14 months.

conclusionsTILs can be manufactured using the CliniMACS Prodigy. Administration of TIL via HAI was safe and feasible in patients with liver-dominant metastatic uveal melanoma. The used regimen appears insufficient to achieve durable clinical efficacy and implies a need for further testing to obtain conclusive results. TRIAL REGISTRATION NUMBERS: NCT04812470, EUCT number: 2024-512877-28-00, EudraCT number: 2020-006126-31.

Indexed as

Immunotherapy, AdoptiveLiver NeoplasmsLymphocytes, Tumor-InfiltratingMelanomaUveal NeoplasmsAdultAgedFemaleHumansMaleMiddle AgedProspective StudiesUveal MelanomaAdoptive cell therapy - ACTTumor infiltrating lymphocyte - TIL

Identifiers

PMID41850738
PMCPMC13007134

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.