Personalized neoantigen peptide vaccines with Leukine for cancer treatment

Pilot Study of Personalized Neoantigen Peptide Vaccines and Leukine for the Treatment of Neoplasms

This study is testing a new personalized cancer vaccine combined with Leukine to see if it can help the immune system better fight different types of cancer.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: Instituto de Medicina Regenerativa (Industry-sponsored)
• Locations: 1 site (Tijuana, Estado de Baja California)
• Trial ID: NCT05475106 on ClinicalTrials.gov

What this trial studies

This pilot clinical trial evaluates the use of personalized neoantigen peptide vaccines combined with Leukine (Sargramostim) in patients with various types of cancer. The approach focuses on inducing immune responses by utilizing unique peptide antigens recognized by T lymphocytes, which can target and destroy cancer cells. The study aims to determine the immunogenicity and effectiveness of these peptide mixtures in eliciting durable T cell responses. Participants will be selected based on specific eligibility criteria, including the presence of confirmed tumors and adequate organ function.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 16 years or older with confirmed tumors and adequate organ function.

Not a fit: Patients without confirmed tumors or those with severely compromised organ function may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance the immune system's ability to recognize and attack cancer cells, potentially leading to improved outcomes for patients.

How similar studies have performed: Other studies using neoantigen peptide vaccines have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 16 years of age or older, male or female
* Life expectancy of at least 3 months
* Confirmed tumor by imaging studies
* Have adequate organ function, as measured by laboratory values: Lymphocyte ratio \>20%; WBC \>3.0×10\^9/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; if the patient has liver metastases, ALT and AST ≤5 × ULN; Alkaline phosphatase (ALP）≤2.5 × ULN; total serum bilirubin (TBIL) \< 1.5 × ULN; Urea nitrogen (BUN）≤1.5 × ULN; Creatinine (Cr）1.5≤ULN; Normal blood coagulation function, urine routine, and electrocardiogram (ECG)
* Available tumor specimen for sequencing and neoantigen determination
* Ability to find 3 or more neoantigen epitopes
* Ability to follow research and follow-up procedures
* Able to understand and willing to sign an IRB approved written informed consent document
* Agree with the use of contraception or partner of child-bearing potential agrees to use adequate contraception which will include two of the following: hormonal or barrier method of birth control, or abstinence prior to study entry, for the duration of study participation, and for 30 days following completion of therapy

Exclusion Criteria:

* History of immunodeficiency disorder or autoimmune condition requiring active immunosuppressive therapy
* Evidence of Liver and kidney dysfunction, severe heart disease, or coagulation dysfunction
* Known diagnosis of an infectious condition including hepatitis, HIV, CMV, and Treponema pallidum
* Participant becomes pregnant and/or is breastfeeding or plans on becoming pregnant during study
* A psychiatric illness that would limit compliance with study requirements as determined by the investigator or the investigator believes that participant is not suitable for inclusion

Where this trial is running

Tijuana, Estado de Baja California

• Instituto de Medicina Regenerativa — Tijuana, Estado de Baja California, Mexico (Recruiting)

Study contacts

• Principal investigator: Jesus Perez, MD — Principal Investigator
• Study coordinator: Jesus Perez, MD

Conditions Neoplasms; tumor; cancer