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

Part of paid clinical trials in Gainesville, Florida.

Sponsor: University of Florida
Study ID: NCT05264974
Phase: PHASE1
Status: Recruiting

Apply to this trial

Conditions

Melanoma
Soft Tissue Sarcoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - 99 Years
Healthy Volunteers: Not accepted

Interventions

Autologous total tumor mRNA loaded DOTAP liposome vaccine — BIOLOGICAL
All participants will receive three doses of RNA-LP vaccine (1 dose every 2 weeks) intravenously. The vaccine dose given will be determined by a 3 + 3 design with cohort sizes of 3 participants. Cohorts will be agnostic of disease indication. Participants will be given one of the following vaccine doses: Dose Level -2: 0.00015625 mg/kg of mRNA encapsulated in 0.00234375 mg/kg lipid particles (LPs) Dose Level -1 (Starting Dose Level): 0.0003125 mg/kg of mRNA encapsulated in 0.0046875 mg/kg LPs Dose Level 0: 0.000625 mg/kg of mRNA encapsulated in 0.009375 mg/kg LPs Dose Level 1: 0.00125 mg/kg mRNA encapsulated in 0.01875 mg/kg LPs Dose Level 2: 0.0025 mg/kg mRNA encapsulated in 0.0375 mg/kg LPs

Study Details

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.