ALT-801

Immunocytokine / IL 2 Fusion ProteinRx: InvestigationalCompound: Investigational

Also known as: ALT801, c264scTCR/IL-2, TCR-IL2 fusion protein

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

ALT-801 is an investigational immunocytokine consisting of a soluble TCR fused to IL-2, designed to selectively deliver IL-2 to p53-overexpressing tumors expressing HLA-A*0201. It has been evaluated in clinical trials for solid tumors including bladder cancer and melanoma, aiming to stimulate anti-tumor immunity with potentially improved tolerability over systemic IL-2.

Mechanism of Action

ALT-801 is a fusion protein combining a soluble T-cell receptor (TCR) domain specific for p53 (aa 264-272) presented by HLA-A*0201 with a single IL-2 molecule. It targets p53-overexpressing tumor cells and delivers IL-2 to the tumor microenvironment, activating NK cells and cytotoxic T lymphocytes to promote anti-tumor immune responses.

Routes of Administration

Intravenous

Goals & Uses

  • NK/T cell activationImmunostimulationModerate
  • Melanoma treatmentOncologyLow
  • Targeted IL-2 deliveryPharmacologyModerate
  • Anti-tumor immunotherapyOncologyModerate
  • Bladder cancer treatmentOncologyModerate

Contraindications

  • Severe cardiopulmonary dysfunctionCardiovascular/PulmonaryHigh
  • Severe autoimmune diseaseImmunologicalHigh
  • HLA-A*0201 negative statusGenetic/HLA RestrictionHigh
  • Active organ transplantation/immunosuppressionImmunologicalModerate

Adverse Effects

  • Lymphocytosis / eosinophiliaHematologicalCommon
  • Flu-like symptoms (fever, chills, fatigue)ConstitutionalCommon
  • HypotensionCardiovascularUncommonLow blood pressure
  • Nausea/vomitingGastrointestinalCommon
  • Injection site / infusion reactionsLocal/SystemicCommon
  • Vascular leak syndromeCardiovascularUncommon

Drug Interactions

  • Antihypertensive agentsModerate
  • CorticosteroidsModerate
  • Other immunosuppressantsModerate

Population Constraints

  • Severe renal or hepatic impairmentOrgan FunctionRelative
  • HLA-A*0201 negative patientsGeneticAbsolute
  • Pediatric patientsAgeRelative
  • Pregnant or breastfeeding womenReproductiveRelative

Regulatory Status

  • European UnionUnknownNo EMA approval; investigational use only.
  • United StatesInvestigationalIND status granted; Phase I/II clinical trials conducted; not FDA approved.
  • United KingdomUnknownNo MHRA approval on record; investigational status.

ALT-801 has been studied in Phase I/II clinical trials. It has received investigational new drug (IND) status in the US but has not received FDA or EMA approval. Development was led by Altor BioScience.

Evidence & Sources

No sources recorded yet.

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