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

Jaime Leandro Foundation for Therapeutic Cancer Vaccines

Status

Conditions: Cancer

Treatments: Biological: Personalized Synthetic Long Peptide Vaccine

Study type: Expanded Access

Funder types: Other

Identifiers

NCT06963697

JLF-100

Details and patient eligibility

About

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.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients must satisfy the following criteria to be enrolled in the protocol:

Main Inclusion Criterion:

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%.

Other Inclusion Criteria:

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.