Clinical trial · Interventional
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
NCT05475106CI-TRIAL-00074766unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoantigen Peptides | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- 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.
- interventionNames
- Biological: Neoantigen Peptides
Primary outcomes (2)
- measure
- Change from Baseline in WBC count
- timeFrame
- Baseline, 2, 6, 12 months
- description
- WBC quantification in blood and comparison at different timepoints
- measure
- Change from Baseline in RBC count
- timeFrame
- Baseline, 2, 6, 12 months
- description
- RBC quantification in blood and comparison at different timepoints
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.