Aldesleukin (Proleukin)

Other Medications · Approved since 1992

US FDA Approved ES Not funded other indication IV 30 Clinical Trials
IL-2 receptor

Description

Aldesleukin is a recombinant interleukin-2 (IL-2) immunotherapy agent that stimulates T-cell proliferation and activation to enhance the body's immune response against cancer cells. In colorectal cancer, it is used as part of combination immunotherapy regimens, particularly with checkpoint inhibitors like PD-1 antibodies, and in adoptive cell therapy protocols using tumor-infiltrating lymphocytes (TILs). The drug serves to amplify the immune system's ability to recognize and destroy colorectal cancer cells, especially in patients with microsatellite stable (MSS) tumors that typically respond poorly to checkpoint inhibitors alone.

Mechanism of Action

Aldesleukin binds to the IL-2 receptor on T-cells and natural killer (NK) cells, triggering intracellular signaling cascades that promote cell division, survival, and cytotoxic function. This leads to expansion of tumor-reactive lymphocytes and enhanced production of inflammatory cytokines that can directly attack cancer cells and recruit additional immune effector cells to the tumor microenvironment.

Molecular Targets

Side Effects

Capillary leak syndrome Hypotension Fever Chills Fatigue Nausea Vomiting Diarrhea Skin rash Fluid retention Confusion Kidney dysfunction Liver toxicity Cardiac arrhythmias Respiratory distress

Not all side effects are listed. Side effects vary by individual. Always consult your oncologist.

Clinical Trials

NCT07255664 Phase 1
Recruiting
A FIH, Phase I/IIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC
Germany
NCT05639972 Phase 1
Recruiting
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
United States
NCT06530303 Phase 1
Recruiting
Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer
China
NCT05686226 Phase 2
Recruiting
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
United States
NCT03190941 Phase 1
Recruiting
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
United States
NCT01174121 Phase 2
Recruiting
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
United States
View all 30 clinical trials →