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

NCT ID: NCT06963697

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: AVAILABLE
• Study Classification: EXPANDED_ACCESS

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

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Patient who qualifies for treatment under 21 CFR 312.305 based on treating physician judgment, inability to enroll in study JLF-200, must have received or be ineligible for FDA-approved therapies for their specific cancer type, and an estimated 5-year survival of less than 50%.

1. >= 12 years of age.

2. ECOG performance status ≤ 2 or Karnofsky score of >=70.

3. Adequate organ function allowing favorable benefit to risk ratio per the treating physician

4. Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration.

5. Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria

1. 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.

2. 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).

3. Psychiatric illness or social situations that would limit compliance with study requirements.

4. 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.

6. Females of non-childbearing potential must be post-menopausal or have been surgically sterilized.

7. 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaime Leandro Foundation for Therapeutic Cancer Vaccines

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Texas Oncology

Austin, Texas, United States

Site Status: AVAILABLE

Countries

United States

Central Contacts

William Hoos

Role: CONTACT

info@jaimeleandrofoundation.org

Other Identifiers

JLF-100

Identifier Type: -

Identifier Source: org_study_id