RecruitingEarly Phase 1NCT05475106

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

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

Sponsor

Instituto de Medicina Regenerativa

Enrollment

100 participants

Start Date

May 12, 2022

Study Type

INTERVENTIONAL

Conditions

Neoplasms

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.

Eligibility

Min Age: 16 Years

Inclusion Criteria9

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 Criteria5

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

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Interventions

BIOLOGICALNeoantigen Peptides

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.