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

Last updated: April 7, 2025
Sponsor: Imugene Limited
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

CF33-CD19 IT

Blinatumomab

CF33-CD19 IV Combination

Clinical Study ID

NCT06063317
CF33-CD19-101
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 tumorwith documented radiological progression per RECIST v1.1. Eligible subjects musthave received at least two prior lines of approved therapies, including targetedtherapies, for which they are eligible and failed or relapsed on or after thattreatment.

  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, laboratorytests, and other study procedures.

Exclusion

Exclusion Criteria:

  1. Prior treatment with a poxvirus based oncolytic virus or a bispecific CD19-directedCD3 T-cell engager.

  2. Continuous systemic treatment with either corticosteroids (>10 mg daily prednisoneequivalents) or other immunosuppressive medications within 4 weeks prior to firstdose 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 requiredsteroids or has current pneumonitis / interstitial lung disease.

  7. History of pancreatitis.

  8. Prior allogeneic tissue/organ transplant or other medical conditions requiringongoing treatment with immunosuppressive drugs or any condition resulting in asystemic immunosuppressed state.

  9. Medical history of central nervous system (CNS) metastases unless the subject hascompleted definitive treatment for the CNS lesions with whole brain radiationtherapy (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, clinicallysignificant valvular heart disease or high-risk uncontrolled arrhythmias.

  11. Bleeding diathesis due to underlying medical condition or ongoing anticoagulationmedication.

  12. History or presence of clinically relevant CNS pathology, or any other CNSdisability judged by the Investigator to be clinically significant and precludinginformed consent or participation in the study.

  13. Active infection requiring systemic treatment.

Study Design

Total Participants: 50
Treatment Group(s): 9
Primary Treatment: CF33-CD19 IT
Phase: 1
Study Start date:
October 02, 2023
Estimated Completion Date:
May 31, 2029

Study Description

CF33-CD19, a novel chimeric orthopoxvirus, will be administered as a monotherapy or in combination with blinatumomab and with or without hydroxyurea to assess the safety and efficacy of the treatment regimens as well as immunological changes in the tumour microenvironment.

Subjects eligible for treatment include those with any metastatic or advanced solid tumor who have documented radiological progression per RECIST following at least two prior lines of therapy.

All enrolled monotherapy subjects will be treated with CF33-CD19 on Day 1 and 8 of Cycle 1 and then on Day 1 of each 21-day cycle thereafter. Subjects treated with the combination regimen will receive CF33-CD19 on Days 1 and 15 of each 28-day cycle. In addition, they will receive blinatumomab as a 7-day continuous infusion from Days 2-9 and Days 16-23 of each cycle.

Connect with a study center

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • Emory Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Northwestern

    Chicago, Illinois 60208
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15219
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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