Allogeneic, Antigen-Presenting, GM-CSF-secreting, SV-BR-1-GM Whole Cell-Therapeutic Vaccine and Immunotherapy: A Phase I Pilot Safety and Feasibility Study for Solid Tumor Patients With CNS Metastases
20 participantsStarted 2026-03-01
Plain-language summary
This is a prospective, single-center, phase 1 basket trial that will evaluate the safety and feasibility of administering SV-BR-1-GM in combination with pembrolizumab to solid tumor oncology patients over nine cycles.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years.
✓. Subject has a prior diagnosis of central nervous system (CNS) metastases per institutional standard of care and/or Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria on imaging.
✓. Subject has disease progression of CNS metastases (brain and/or leptomeningeal metastases (LMD) ) with progression on ≥ 1 line of standard of care therapy.
✓. Patients should have at least one metastasis approved by the research team that meets the following size requirements:
✓. Patients with recurrent and or progressive symptomatic or asymptomatic brain lesions and \>0.5 cm and twice the magnetic resonance imaging (MRI) slice thickness are allowed.
✓. Any recurrent or progressive brain lesions \> 3 cm in size and or causing symptoms must be evaluated by the study team for SRC and or whole brain radiation therapy (WBRT) prior to study entry.
✓. Patients with recurrent brain lesions that are not treatable with local therapy or WBRT are eligible.
✓. An interval of at least 4 weeks after the end of whole brain radiation or for any surgical resection of brain lesions is permitted; an interval of at least 4 weeks or 5 half-lives (whichever is sorter) after the last cytotoxic, targeted, immunotherapeutic or investigational agent is permitted (prior to the start of DC vaccine).
Exclusion criteria
✕. History of allergic reactions or intolerance to immunotherapy.
✕
What they're measuring
1
Grade 3 or higher adverse events
Timeframe: 30 days after the beginning of study therapy, 9 months after the beginning of study therapy
2
Study therapy duration
Timeframe: 6 months
Trial details
NCT IDNCT07199413
SponsorMedical College of Wisconsin
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2029-04-01
Contact for this trial
Medical College of Wisconsin Cancer Center Clinical Trials Office
. History of active or untreated infection, such as chronic untreated infections, HIV, Hepatitis B, Hepatitis C, or tuberculosis.
✕. History of active inflammatory or autoimmune disease (granulomatosis, polyangiitis, Graves' disease, rheumatoid arthritis, polyphisitis, uveitis, etc.), except for the following.
✕. Vitiligo; alopecia
✕. Hypothyroidism: stable on replacement therapy
✕. Chronic skin disease that doesn't require steroid therapy.
✕. Active celiac disease or inflammatory bowel disease
✕. Presence of severe neurological symptoms and unable to participate in the study due to acute decompensation.