CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative Breast Cancer

NCT05081492 | Active Not Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 21094NCI-2021-08983P30CA033572
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Triple-Negative Breast Carcinoma; Prognostic Stage IV Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Toxicity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0. Observed toxicities/adverse events will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.

  Up to 30 days

Secondary Outcomes (9)

• Immune Biomarker Expression

  Up to 6 months

• Optimal biologic dose

  Up to 3 months

• Response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  Up to 6 months

• Response rate based on immune related iRECIST

  Up to 6 months

• Progression free survival

  Up to 1 year

Study Arms (1)

Treatment (CF33-hNIS-antiPDL1)

EXPERIMENTAL

Patients receive CF33-hNIS-antiPDL1 IT on days 1 and 15. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

Biological: Oncolytic Virus CF33-expressing hNIS/Anti-PD-L1 Antibody

Interventions

Oncolytic Virus CF33-expressing hNIS/Anti-PD-L1 Antibody BIOLOGICAL

Given IT

Also known as: CF33 Expressing hNIS-Anti-PD-L1 Antibody, CF33-hNIS-antiPDL1

Treatment (CF33-hNIS-antiPDL1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented informed consent of the participant and/or legally authorized representative
• Assent, when appropriate, will be obtained per institutional guidelines
• Agreement to research biopsies on study, once during study and end of study, exceptions may be granted with study principal investigator (PI) approval
• \>= 18 years
• Eastern Cooperative Oncology Group (ECOG) =\< 2
• Histologically confirmed metastatic triple negative breast cancer. Triple negative status will be defined as estrogen receptor (ER) and progesterone receptor (PR) =\< 10% by immunohistochemistry (IHC) and HER2 negative, per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
• Measurable disease by RECIST 1.1
• Patients must have progressed on or been intolerant of at least 2 prior lines of therapy for advanced/metastatic disease. Patients that qualify for immunotherapy and/or PARP inhibitors must have progressed on or been intolerant of these agents
• Fully recovered from the acute toxic effects (except alopecia) to =\< grade 2 to prior anti-cancer therapy
• Must have a superficial tumor (cutaneous, subcutaneous), breast lesion or nodal metastases amenable to safe repeated intratumoral injections per treating physician and interventional radiologist review
• Absolute neutrophil count (ANC) \>= 1,500/mm\^3
• NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
• Platelets \>= 100,000/mm\^3
• NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
• Total bilirubin =\< 1.5 X upper limit of normal (ULN)

You may not qualify if:

• Chemotherapy, biological therapy, immunotherapy or investigational therapy within 14 days prior to day 1 of protocol therapy
• Major surgery or radiation therapy within 28 days of study therapy
• Has received a vaccination within 30 days of first study injection
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
• Clinically significant uncontrolled illness
• Active infection requiring antibiotics
• Known history of immunodeficiency virus (HIV)
• Patients with a known history of hepatitis B or hepatitis C infection who have active disease as evidenced by hepatitis (Hep) B surface antigen status or Hep C polymerase chain reaction (PCR) status obtained within 14 days of cycle 1, day 1
• Another malignancy within 3 years, except non-melanomatous skin cancer
• Females only: Pregnant or breastfeeding
• Patients may not have clinically unstable brain metastases. Patients may be enrolled with a history of treated brain metastases that are clinically stable for \>= 4 weeks prior to start of study treatment
• Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator
• Imugene Limited: collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Related Publications (2)

• Rand J, Yamauchi D, Chaurasiya S, Zhang J, Deshpande S, Chong L, Seiz A, Meisen H, Fong Y, Yuan Y. hNIS-based imaging to monitor treatment with the novel oncolytic virus CF33-hNIS-antiPDL1 in humans with advanced triple negative breast cancer. Front Oncol. 2025 Aug 25;15:1565244. doi: 10.3389/fonc.2025.1565244. eCollection 2025.

  PMID: 40933893 DERIVED

• Yuan Y, Egelston C, Colunga Flores O, Chaurasiya S, Lin D, Chang H, Chong LMO, Seiz A, Shah M, Meisen WH, Tang A, Martinez N, Pickett W, Murga M, Yost SE, Stewart D, Zhang J, Ede N, Modi B, Kessler J, Rand J, Fong Y. CF33-hNIS-anti-PD-L1 oncolytic virus followed by trastuzumab-deruxtecan in a patient with metastatic triple negative breast cancer: a case study. Ther Adv Med Oncol. 2023 Nov 10;15:17588359231210675. doi: 10.1177/17588359231210675. eCollection 2023.

  PMID: 38028143 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jamie Rand

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 18, 2021
• Study Start: October 18, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)