Combining onCARlytics with Blinatumomab for advanced solid tumors

A Phase I, Dose Escalation and Dose Expansion, Safety and Tolerability Study of onCARlytics (CF33-CD19), Administered Intravenously or Intratumorally in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS)

This study is testing a new virus treatment combined with a medication to see if it can help adults with advanced solid tumors who haven't responded to previous therapies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Imugene Limited (Industry-sponsored)
• Drugs / interventions: radiation, prednisone, blinatumomab
• Locations: 8 sites (Duarte, California and 7 other locations)
• Trial ID: NCT06063317 on ClinicalTrials.gov

What this trial studies

This open-label, phase I study evaluates the safety and tolerability of CF33-CD19, a novel oncolytic virus, administered either intravenously or intratumorally, in combination with blinatumomab for adults with advanced or metastatic solid tumors. The study involves a dose escalation and expansion approach to assess the efficacy of the treatment regimens and the immunological changes within the tumor microenvironment. Eligible participants must have documented radiological progression after at least two prior lines of therapy and will receive treatment in a structured cycle format.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic solid tumors that have progressed after at least two prior therapies.

Not a fit: Patients who have previously received treatment with a poxvirus-based oncolytic virus or a bispecific CD19-directed T-cell engager may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: While the combination of oncolytic viruses and bispecific T-cell engagers is a novel approach, similar studies have shown promising results in enhancing anti-tumor immunity.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent from subject or legally authorized representative.
2. Age ≥ 18 years old on the date of consent.
3. Life expectancy of at least 3 months.
4. Any histologically or cytologically confirmed advanced or metastatic solid tumor with documented radiological progression per RECIST v1.1. Eligible subjects must have received at least two prior lines of approved therapies, including targeted therapies, for which they are eligible and failed or relapsed on or after that treatment.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
6. At least one measurable lesion as defined by RECIST v1.1 criteria.
7. Adequate renal function.
8. Adequate hepatic function.
9. Adequate hematologic function.
10. Willing and able to comply with scheduled visits, study treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Prior treatment with a poxvirus based oncolytic virus or a bispecific CD19-directed CD3 T-cell engager.
2. Continuous systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
3. Any radiation within 2 weeks of start of study treatment.
4. Active autoimmune disease.
5. Current or history of severe skin disease with open wounds.
6. History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
7. History of pancreatitis.
8. Prior allogeneic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state.
9. Medical history of central nervous system (CNS) metastases unless the subject has completed definitive treatment for the CNS lesions with whole brain radiation therapy (WBRT) or stereotactic radiosurgery (SRS) and are neurologically stable, asymptomatic, and off corticosteroids for at least 2 months prior to first dose.
10. History of documented congestive heart failure (New York Heart Association \[NYHA\] class II - IV), unstable angina, poorly controlled hypertension, clinically significant valvular heart disease or high-risk uncontrolled arrhythmias.
11. Bleeding diathesis due to underlying medical condition or ongoing anticoagulation medication.
12. History or presence of clinically relevant CNS pathology, or any other CNS disability judged by the Investigator to be clinically significant and precluding informed consent or participation in the study.
13. Active infection requiring systemic treatment.

Where this trial is running

Duarte, California and 7 other locations

• City of Hope — Duarte, California, United States (Recruiting)
• Emory Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
• Northwestern — Chicago, Illinois, United States (Recruiting)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Recruiting)
• University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Yuni Kim

Conditions Solid Tumor, Adult; Immunotherapy; Oncolytic Virus; Bispecific T-Cell Engager; BiTE; Blincyto