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