Table of Contents
- Clinical trial overview
- Cancer studies using Aldesleukin
- Immune and other non-cancer studies
- Trial phases and who can join
- What the trials measure
- Important patient terms
Clinical trial overview
Aldesleukin appears in a wide range of interventional studies, mostly as part of combination treatment plans in cancer and immune-related conditions.[1] The trial data include studies that are completed, authorised, and in different phases from Phase 1 to Phase 3.[1]
Many studies are designed to check safety and tolerability first, then look for early signs that the treatment may help the disease.[1][2] Some trials also compare one treatment strategy against another, especially in larger Phase 3 research.[2]
Cancer studies using Aldesleukin
Several trials study advanced cancers, including metastatic melanoma, pancreatic cancer, colorectal cancer, cervical cancer, non-small-cell lung cancer, lymphoma, and other solid tumors.[1][2][3][4]
In NCT04243499, researchers studied ICT01 with low-dose subcutaneous interleukin-2 in people with advanced solid tumors, and the main goal was to assess safety, tolerability, and disease control rate.[1] The study included conditions such as metastatic castration-resistant prostate cancer, metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, metastatic or unresectable refractory melanoma, and metastatic ovarian cancer.[1]
NCT03645928 studied tumor-infiltrating lymphocytes, also called TILs, in solid tumors, with Aldesleukin listed among the treatment drugs.[2] The main outcome was objective response rate, which means the share of patients whose tumors shrank or disappeared based on standard scan rules.[2]
NCT03108495 studied LN-145 in recurrent, metastatic, or persistent cervical carcinoma, and Aldesleukin was part of the treatment plan.[3] The study measured objective response rate in some cohorts and treatment-emergent adverse events in another cohort.[3]
NCT04614103 focused on metastatic non-small-cell lung cancer and used LN-145 with Aldesleukin as part of the regimen.[4] The study measured objective response rate by the Independent Review Committee or the Investigator, depending on the cohort.[4]
NCT05727904 is a Phase 3 study in untreated advanced melanoma that compares lifileucel plus pembrolizumab with pembrolizumab alone.[5] The main endpoint is progression-free survival, which is the time until the disease gets worse or the patient dies.[5]
2025-521227-70-00 is a first-in-human Phase 1/2a study in locally advanced or metastatic prostate cancer and metastatic colorectal cancer, and it includes repeated administrations of a novel tumor-infiltrating lymphocyte-based immunotherapy with Proleukin in the regimen.[6] The study focuses on safety, tolerability, feasibility, and whether patients can receive at least two TIL administrations without treatment-limiting side effects.[6]
2023-504632-17-00 studies autologous TIL therapy in advanced tumors with SWI/SNF complex alterations, and the main outcome is objective response rate.[7] This trial is important because it targets a specific tumor biology feature, not just one cancer type.[7]
2023-506400-99-00 compares an IL-2 analog strategy with high-dose IL-2 after TIL therapy in melanoma, non-small-cell lung cancer, and cervical cancer.[8] It measures serious side effects in the first two weeks and also patient-reported outcomes, which are symptom scores reported directly by patients.[8]
Immune and other non-cancer studies
Not all Aldesleukin-related trials are in cancer.[9][10][11]
2024-519532-16-00 studies people with idiopathic inflammatory myositis, systemic lupus erythematosus, and systemic sclerosis.[9] The trial is designed to assess safety of CNTY-101, and Aldesleukin is listed in the intervention list.[9]
2023-510297-14-00 is a basket trial in primary sclerosing cholangitis, mucous membrane pemphigoid, polymyositis/dermatomyositis, and pemphigus vulgaris/foliaceus.[10] The study looks at the Treg response, meaning changes in regulatory T cells, and also tracks disease activity over time.[10]
NCT04166006 studies vaccine treatment after surgery for stage IV rare cancers, including neuroendocrine tumors and soft tissue sarcoma.[11] The study measures grade 3 or higher adverse events and immune effectors, which are immune cells that help fight disease.[11]
NCT05468073 studies early Alzheimer disease and compares treated patients with placebo, with the main endpoint being rate of decline measured by CDR change at 18 months.[12] NCT05153070 studies recent-onset type 1 diabetes with residual insulin secretion and measures changes in Tregs after repeated low-dose interleukin-2.[13] 2025-522841-23-00 studies children with autism spectrum disorder and measures the change in Tregs from baseline to day 8 compared with placebo.[14]
Trial phases and who can join
The trial phases range from Phase 1 to Phase 3.[1][5] Phase 1 studies usually focus on safety and early dose finding, while Phase 2 studies often look at whether the treatment shows activity in a specific disease.[1][2] Phase 3 studies are larger and compare treatment strategies in a more formal way.[5]
Who can join depends on the trial.[1][6][9][14]
Some studies include adults with advanced or metastatic cancers, such as melanoma, colorectal cancer, pancreatic cancer, prostate cancer, cervical cancer, lung cancer, lymphoma, or other solid tumors.[1][3][4][5][6]
Some studies include people with active autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, polymyositis/dermatomyositis, pemphigus, pemphigoid, or primary sclerosing cholangitis.[9][10]
Other studies include children with autism spectrum disorder or adults with early Alzheimer disease or recent-onset type 1 diabetes.[12][13][14]
Some trials also require progressive disease, meaning the disease is getting worse before the study starts.[6]
What the trials measure
Across the studies, the most common endpoints are safety and treatment activity.[1][2][3]
Safety and tolerability: trials count adverse events, serious adverse events, and dose-limiting toxicities to see how well the treatment can be given.[1][3][6]
Objective response rate: some cancer trials measure how many patients have a confirmed complete or partial response under RECIST rules.[2][3][4][7]
Disease control rate: one study includes stable disease, partial response, or complete response as the main disease control measure.[1]
Progression-free survival: the Phase 3 melanoma study measures the time until disease progression or death.[5]
Immune markers: several studies measure Tregs or other immune effectors to see how the immune system changes during treatment.[10][11][13][14]
Patient-reported outcomes: one study also checks symptoms reported by patients, such as fatigue, rash, pain, and shortness of breath.[8]
Important patient terms
Interventional study means the researchers give a treatment and then measure what happens.[1] Open-label means both the researchers and participants know which treatment is being given.[1] Randomized means participants are assigned to different treatment groups by chance.[5]
RECIST is a standard set of rules used to measure tumor changes on scans.[2][3][4][7] CTCAE is a standard system for grading side effects by severity.[1][3][6]
Basket trial means one study looks at several diseases or tumor types at the same time.[10] First-in-human means the treatment is being studied in people for the first time.[6] Autologous means the cells come from the same person who receives them.[2][7]
