A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS)

Stopped early · Phase 1

Conditions studied: Solid Tumor, Adult

In brief

This is an open-label, dose escalation and dose expansion, multi-center phase I study evaluating the safety and tolerability of CF33-CD19 administered intravenously (IV) or intratumorally (IT) in combination with blinatumomab and with or without hydroxyurea in adults with advanced or metastatic solid tumors.

Key facts

Study ID

NCT06063317

Run by

Imugene Limited

People needed

25

Starts

2023-10-02

Expected to finish

2026-02-02

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent from subject or legally authorized representative.
• Age ≥ 18 years old on the date of consent.
• Life expectancy of at least 3 months.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
• At least one measurable lesion as defined by RECIST v1.1 criteria.
• Adequate renal function.
• Adequate hepatic function.
• Adequate hematologic function.
• Willing and able to comply with scheduled visits, study treatment plan, laboratory tests, and other study procedures.

You may not qualify if…

• Prior treatment with a poxvirus based oncolytic virus or a bispecific CD19-directed CD3 T-cell engager.
• 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.
• Any radiation within 2 weeks of start of study treatment.
• Active autoimmune disease.
• Current or history of severe skin disease with open wounds.
• History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
• History of pancreatitis.
• Prior allogeneic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state.
• 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.
• 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.
• Bleeding diathesis due to underlying medical condition or ongoing anticoagulation medication.
• 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.
• Active infection requiring systemic treatment.

Where it is running

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

Full record on ClinicalTrials.gov

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