Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization
United States18 participantsStarted 2026-03-17
Plain-language summary
The goal of this phase I trial is to evaluate the toxicity and feasibility of a tumor-specific RNA-NP vaccine in patients with stage IIB-IV melanoma who have evidence of progressive disease by RECIST 1.1 criteria while receiving adjuvant aPD1 therapy, or those who progress within 6 months of completion of adjuvant treatment, or unresectable stage II soft tissue sarcoma or stage III-IV soft tissue sarcoma.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria:
* Adults ≥ 18 years old
* ECOG performance ≤ 2
* Lab values within the specified ranges:
* Hemoglobin ≥ 8G/DL
* Platelets ≥ 150 thou/cumm
* Absolute Neutrophil Count (ANC) ≥ 1500 thou/cumm
* Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* AST and ALT ≤ 2.5 x ULN; If confirmed liver metastases: AST and ALT ≤ 5 x ULN
* Creatinine clearance (CrCl) ≥ 15 ml/min (based on modified Cockcroft and Gault formula)
* Must have disease that is amenable to surgical sampling for RNA extraction, amplification, and loading of lipid particles
* Subjects must not have more than one active malignancy at the time of enrollment (subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician and approved by the PI\] may be included)
* Written informed consent obtained from the subject.
* Female subjects of childbearing potential must have a negative serum pregnancy test at screening
* Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least four months after the last dose of study treatment to minimize the risk of pregnancy. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an un…