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

Active:	Yes
Cancer Type:	Solid Tumor Unknown Primary	NCT ID:	NCT06063317
Trial Phases:	Phase I	Protocol IDs:	CF33-CD19-101 (primary) NCI-2023-08528
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Imugene Limited
NCI Full Details:	http://clinicaltrials.gov/show/NCT06063317

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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