Pilot Study of Neoantigen Peptides and Leukine for the Treatment of Neoplasms

NCT05475106 | Recruiting Early Phase 1

• 1 other identifier: PEP-NEO-002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is a pilot clinical trial using personalized neoantigen peptide vaccines with the addition of Leukine (Sargramostim), in patients with different types of cancer.

Conditions

Neoplasms

Keywords

tumor; cancer

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in WBC count

  WBC quantification in blood and comparison at different timepoints

  Baseline, 2, 6, 12 months

• Change from Baseline in RBC count

  RBC quantification in blood and comparison at different timepoints

  Baseline, 2, 6, 12 months

Secondary Outcomes (5)

• Change from Baseline in Calcitonin levels

  Baseline, 2, 6, 12 months

• Change from Baseline in CA-125 levels at

  Baseline, 2, 6, 12 months

• Change from Baseline in beta-2-microglobulin levels

  Baseline, 2, 6, 12 months

• Change from Baseline in sum of diameter of target lesions

  Baseline, 2, 6, 12 months

• Change from Baseline in sum of diameter of non-target lesions

  Baseline, 2, 6, 12 months

Study Arms (1)

Treatment

EXPERIMENTAL

Patients will receive intradermal injection of individualized neoantigen peptides vaccine at a dose of \~500ug per peptide once a week for 4 weeks and once every month after that for 5 months.

Biological: Neoantigen Peptides

Interventions

Neoantigen Peptides BIOLOGICAL

Patients will receive intradermal injection of individualized neoantigen peptides vaccine at a dose of \~500ug per peptide once a week for 4 weeks, and every month for 5 months after that.

Treatment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Medicina Regenerativa: lead

Study Sites (1)

Instituto de Medicina Regenerativa

Tijuana, Estado de Baja California, 22100, Mexico

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jesus Perez, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesus Perez, MD

CONTACT

526641430480; jesus.perez.md@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 26, 2022
• Study Start: May 12, 2022
• Primary Completion: November 25, 2025
• Study Completion (Estimated): June 20, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-01

Locations

ME (1)