A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS)
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
CF33-CD19-101 (primary)
NCI-2023-08528
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 in adults with advanced or
metastatic solid tumors.
Objectives
CF33-CD19, a novel chimeric orthopoxvirus, will be administered as a monotherapy or in
combination with blinatumomab 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.
Eligibility
- 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.
Treatment Sites in Georgia
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