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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

NCT07199413 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-30

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

SV-BR-1-GM Vaccine

\~20 X 10\^6 cells across 4 injection sites

DRUG

Cyclophosphamide

300 mg/m\^2 Intravenous

DRUG

Pembrolizumab

200 mg/m\^2 Intravenous

DRUG

Interferon

0.18 mcg subcutaneous

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2029-04-01
Completion
2029-04-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07199413 on ClinicalTrials.gov