Oncolytic Virus CF33-expressing hNIS/Anti-PD-L1 Antibody for Breast Cancer
Trial Summary
What is the purpose of this trial?
This phase I trial tests the safety, side effects, and best dose of CF33-hNIS-antiPDL1 in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic). CF33-hNIS-antiPDL1 is an oncolytic virus. This is a virus that is designed to infect tumor cells and break them down.
Will I have to stop taking my current medications?
The trial requires that you stop chemotherapy, biological therapy, immunotherapy, or investigational therapy at least 14 days before starting the study treatment. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.
What data supports the effectiveness of the treatment CF33-hNIS-antiPDL1 for breast cancer?
The treatment CF33-hNIS-antiPDL1 has shown promise in preclinical studies for triple-negative breast cancer, where it demonstrated anti-tumor effects in mice without causing harmful side effects. Additionally, similar treatments have been effective in enhancing immune responses against other cancers, like pancreatic and gastric cancer, suggesting potential benefits for breast cancer as well.12345
Is the treatment CF33-hNIS-antiPDL1 generally safe for humans?
What makes the treatment CF33-hNIS-antiPDL1 unique for breast cancer?
CF33-hNIS-antiPDL1 is unique because it uses a genetically modified virus to directly attack cancer cells and boost the immune system's response by blocking PD-L1, a protein that helps cancer cells hide from immune attacks. This approach is particularly novel for triple-negative breast cancer, which is typically hard to treat with standard therapies.12345
Research Team
Jamie Rand
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for adults with metastatic triple negative breast cancer who have tried at least two treatments without success. Participants must not be pregnant, breastfeeding, or have other cancers; they should also agree to use birth control and provide biopsies. They need normal blood counts, liver function within certain limits, and cannot join if they've had recent vaccines or infections.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive CF33-hNIS-antiPDL1 intratumorally on days 1 and 15, repeating every 28 days for up to 3 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Long-term follow-up
Participants are monitored for overall survival and progression-free survival
Treatment Details
Interventions
- CF33-hNIS-antiPDL1
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
Imugene Limited
Industry Sponsor
National Cancer Institute (NCI)
Collaborator