Expanded Access To Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors

NCT06963697 | Unknown

• 1 other identifier: JLF-100
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is an intermediate patient expanded access protocol for treatment of patients with local or metastatic solid tumors with a neoantigen synthetic long peptide vaccine.

Conditions

Cancer

Interventions

Personalized Synthetic Long Peptide Vaccine BIOLOGICAL

Neoantigen synthetic long peptide vaccines are composed of synthetic long peptides which are 8-35 amino acids in length and designed to induce immune responses to cancer neoantigens identified by exome sequencing. Neoantigen synthetic long peptide vaccines will be co-administered with poly-ICLC, an innate immune adjuvant capable of activating TLR3 and other pathways.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 12 years of age.
• ECOG performance status ≤ 2 or Karnofsky score of \>=70.
• Adequate organ function allowing favorable benefit to risk ratio per the treating physician
• Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration.
• Ability to understand and willingness to sign an IRB approved written informed consent document.

You may not qualify if:

• History of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty or known allergy to a component of the neoantigen synthetic long peptide vaccine.
• Intercurrent illness requiring chronic use of medications that may interfere with rescue medications for treatment of vaccine-related anaphylaxis or attenuate immune response to vaccine treatment (immunosuppressive therapies).
• Psychiatric illness or social situations that would limit compliance with study requirements.
• History of pre-existing immunodeficiency disorder or autoimmune condition requiring immunosuppressive therapy that would preclude response to vaccine. 5. Females of childbearing potential may participate provided they agree to practice abstinence; and, if heterosexually active, agree to use at least 2 highly effective contraceptive methods throughout the study and for 3 months following the last dose of study drug; and have a negative serum pregnancy test.
• \. Females of non-childbearing potential must be post-menopausal or have been surgically sterilized.
• \. Male subjects with a female partner of childbearing potential must agree to practice abstinence or to use a physician-approved contraceptive method throughout the study and for 3 months following the last dose of study drug.

Sponsors & Collaborators

• Jaime Leandro Foundation for Therapeutic Cancer Vaccines: lead

Study Sites (1)

Texas Oncology

Austin, Texas, 78705, United States

AVAILABLE

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

William Hoos

CONTACT

info@jaimeleandrofoundation.org

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: May 9, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

US (1)