Status:
COMPLETED
Pilot Study of Neoantigen Peptides for the Treatment of Neoplasms
Lead Sponsor:
Instituto de Medicina Regenerativa
Conditions:
Neoplasms
Eligibility:
All Genders
16-70 years
Phase:
EARLY_PHASE1
Brief Summary
This research is a pilot clinical trial using personalized neoantigen peptide vaccines with an adjuvant (Montanide ISA-51 VG), in patients with different types of cancer
Detailed Description
Rationale: Cancer cells express unique peptide antigens recognized by CD8+ cytotoxic T lymphocytes (CTL), which are typically 8-10 amino acids long and are presented in association with Class I MHC mo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04509167
Start Date
August 10 2020
End Date
June 24 2022
Last Update
March 6 2024
Active Locations (1)
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1
Instituto de Medicina Regenerativa
Tijuana, Estado de Baja California, Mexico, 22100