Interleukin-15, human recombinant

Summary

Human recombinant IL-15 is an investigational cytokine being evaluated primarily in oncology settings as an immunostimulatory agent. It stimulates NK and CD8+ T cell expansion and is explored as monotherapy or in combination with checkpoint inhibitors and other immunotherapies for cancer treatment.

Mechanism of Action

Binds to the IL-15 receptor complex (IL-15Rα/IL-2Rβ/γc), activating JAK1/JAK3 and STAT3/STAT5 signaling pathways. Promotes proliferation, survival, and activation of CD8+ T cells, NK cells, and NKT cells; supports memory T cell homeostasis and innate immune responses.

Routes of Administration

Goals & Uses

• NK cell expansionImmunologyHigh
• Combination with checkpoint inhibitorsOncologyModerate
• CD8+ memory T cell homeostasisImmunologyHigh
• HIV immunotherapy / viral reservoir reductionInfectious DiseaseLow
• Cancer immunotherapyOncologyModerate

Contraindications

• Severe hepatic or renal impairmentOrgan ImpairmentModerate
• Organ transplant recipients on immunosuppressionTransplantHigh
• Active systemic infectionInfectiousHigh
• Active autoimmune diseaseAutoimmunityHigh

Adverse Effects

• Injection site reactionsLocalCommon
• ThrombocytopeniaHematologicCommonLow platelet count
• Cytokine release syndrome (CRS)ImmunologicalCommon
• HypotensionCardiovascularUncommonLow blood pressure
• Liver enzyme elevation (transaminitis)HepaticUncommon
• FatigueGeneralCommonLow energy or tiredness

Drug Interactions

• Anti-PD-1/PD-L1 agents (e.g., pembrolizumab, nivolumab)Moderate
• Other pro-inflammatory cytokines (e.g., IL-2, IL-21)Moderate
• Immunosuppressive agents (e.g., cyclosporine, tacrolimus)High
• CorticosteroidsModerate

Population Constraints

• Pediatric patientsAgeRelative
• Elderly patients (>75 years)AgeRelative
• Pregnant or lactating womenReproductiveRelative
• Patients with prior severe CRS or immunological toxicityMedical HistoryRelative

Regulatory Status

• European UnionInvestigationalUnder EMA investigational review; no approved indications as of 2024.
• United StatesInvestigationalMultiple IND applications; studied by NCI and academic centers. No FDA approval as of 2024.
• United KingdomInvestigationalNo MHRA approval; investigated in clinical trials within academic frameworks.

No FDA or EMA approved indication as of 2024. Multiple Phase I/II clinical trials ongoing under IND. Has received no approved status in US, EU, or UK. Investigated by NCI and various pharmaceutical sponsors.

Evidence & Sources

No sources recorded yet.