RecruitingPhase 1NCT05264974

Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization

Sponsor

University of Florida

Enrollment

18 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Soft Tissue Sarcoma Melanoma

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a personalized RNA vaccine made from a patient's own tumor — combined with an anti-PD-1 immunotherapy drug — to see if it can help the immune system better fight cancer. Each vaccine is custom-made using genetic material extracted from the patient's own tumor cells. **You may be eligible if...** - You are 18 years or older - You are in generally good health (ECOG 0–2) - You have a solid tumor that can be surgically sampled to extract RNA - You have only one active cancer at the time of enrollment - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your tumor cannot be safely sampled for RNA extraction - You have active autoimmune disease requiring treatment - You have recently received chemotherapy, immunotherapy, or radiation therapy (within defined washout periods) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous total tumor mRNA loaded DOTAP liposome vaccine

All participants will receive three doses of RNA-NP vaccine (1 dose every 2 weeks) intravenously. The vaccine dose given will be determined by a 3 + 3 design. Participants will be given one of the following vaccine doses: Dose level 0 (starting dose level): 0.00125 mg/kg mRNA in 0.01875 mg/kg LP; Dose level 1: 0.0025 mg/kg mRNA in 0.0375 mg/kg LP; Dose level 2: 0.005 mg/kg mRNA in 0.075 mg/kg LP; or Dose level 3: 0.01 mg/kg mRNA in 0.15 mg/kg LP If 3 or more of the initial 6 subjects experience a dose-limiting toxicity, then the initial starting dose will be reduced (dose de-escalation) to 0.000625 mg/kg mRNA encapsulated in 0.009375mg/kg LPs (Dose level -1).