ALT-801
Also known as: ALT-801, ALT801, c264scTCR/IL-2, IL-2‑fusion peptide, TCR-IL2 fusion protein
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Summary
ALT‑801 is a recombinant fusion protein combining a modified interleukin‑2 with a peptide that improves tumor localization. It is being evaluated in clinical trials for solid tumours and hematologic malignancies.
Mechanism of Action
IL-2 variant fused to a tumor‑targeting peptide; selectively activates IL-2 receptors on activated T cells and NK cells, enhancing anti‑tumor immunity while reducing systemic toxicity.
Routes of Administration
Goals & Uses
- NK/T cell activationImmunostimulationModerate
- Melanoma treatmentOncologyLow
- Targeted IL-2 deliveryPharmacologyModerate
- Anti-tumor immunotherapyOncologyModerate
- Cancer immunotherapyOncologyModerate
- Bladder cancer treatmentOncologyModerate
Contraindications
- Organ transplantationTransplantHigh
- Severe cardiopulmonary dysfunctionCardiovascular/PulmonaryHigh
- Severe autoimmune diseaseImmunologicalHigh
- HLA-A*0201 negative statusGenetic/HLA RestrictionHigh
- Active organ transplantation/immunosuppressionImmunologicalModerate
Adverse Effects
- Cytokine release syndromeImmunologicCommonSystemic inflammatory response from immune activation
- Lymphocytosis / eosinophiliaHematologicalCommon
- Capillary leak syndromeVascularUncommonLeakage of fluid from blood vessels into tissues
- Flu-like symptoms (fever, chills, fatigue)ConstitutionalCommon
- HypotensionCardiovascularUncommonLow blood pressure
- Nausea/vomitingGastrointestinalCommon
- Injection site / infusion reactionsLocal/SystemicCommon
- Vascular leak syndromeCardiovascularUncommon
- Elevated liver enzymesHepaticUncommonIncrease in AST/ALT or other hepatic markers
Drug Interactions
- Antihypertensive agentsModerate
- CyclosporineModerate
- CorticosteroidsModerate
- Other immunosuppressantsModerate
Population Constraints
- Severe renal or hepatic impairmentOrgan FunctionRelative
- HLA-A*0201 negative patientsGeneticAbsolute
- Pediatric patientsAgeRelative
- Pregnant or breastfeeding womenReproductiveRelative
- Pregnant womenReproductiveAbsolute
Regulatory Status
- European UnionInvestigationalClinical development under EMA oversight.
- United StatesInvestigationalPhase II trials ongoing; 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.
Frequently Asked Questions
What is ALT-801?
ALT‑801 is a recombinant fusion protein combining a modified interleukin‑2 with a peptide that improves tumor localization. It is being evaluated in clinical trials for solid tumours and hematologic malignancies.
What is ALT-801 used for?
ALT-801 is educationally associated with: NK/T cell activation, Melanoma treatment, Targeted IL-2 delivery, Anti-tumor immunotherapy, Cancer immunotherapy, Bladder cancer treatment. Educational only — not medical advice.
How is ALT-801 administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of ALT-801?
Reported adverse effects include: Cytokine release syndrome, Lymphocytosis / eosinophilia, Capillary leak syndrome, Flu-like symptoms (fever, chills, fatigue), Hypotension, Nausea/vomiting, Injection site / infusion reactions, Vascular leak syndrome, Elevated liver enzymes. This list is not exhaustive — consult a qualified clinician.
Who should avoid ALT-801?
Recorded contraindications: Organ transplantation, Severe cardiopulmonary dysfunction, Severe autoimmune disease, HLA-A*0201 negative status, Active organ transplantation/immunosuppression. Consult a qualified clinician before use.