Trial Title:
A Study of OnCARlytics (CF33-CD19) in Combination with Blinatumomab in Adults with Advanced or Metastatic Solid Tumors (OASIS)
NCT ID:
NCT06063317
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Neoplasms
Blinatumomab
Conditions: Keywords:
Immunotherapy
Oncolytic Virus
Bispecific T-Cell Engager
BiTE
Blincyto
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CF33-CD19 IT
Description:
Safety Run-In Phase: CF33-CD19 will be administered intratumorally on Days 1 and 8 of
Cycle 1 and Day 1 of each subsequent 21-day cycle.
Dose Escalation Combination Phase: CF33-CD19 will be administered intratumorally on Days
1 and 15 of each 28-day cycle.
Arm group label:
CF33-CD19 IT Administration Monotherapy
Arm group label:
CF33-CD19 IT Administration in Combination with Blinatumomab
Intervention type:
Biological
Intervention name:
CF33-CD19 IV
Description:
Safety Run-In Phase: CF33-CD19 will be administered intravenously on Days 1 and 8 of
Cycle 1 and Day 1 of each subsequent 21-day cycle.
Dose Escalation Combination Phase: CF33-CD19 will be administered intravenously on Days 1
and 15 of each 28-day cycle.
Arm group label:
CF33-CD19 IV Administration Monotherapy
Arm group label:
CF33-CD19 IV Administration in Combination with Blinatumomab
Intervention type:
Biological
Intervention name:
Blinatumomab
Description:
Blinatumomab will be infused via a 7-day continuous infusion from Days 2-9 and Days 16-23
of each 28-day cycle.
Arm group label:
CF33-CD19 IT Administration in Combination with Blinatumomab
Arm group label:
CF33-CD19 IV Administration in Combination with Blinatumomab
Other name:
Blincyto
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.
Detailed description:
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.
Criteria for 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. > Grade 2 neuropathy.
9. Prior allogeneic tissue/organ transplant or other medical conditions requiring
ongoing treatment with immunosuppressive drugs or any condition resulting in a
systemic immunosuppressed state.
10. 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.
11. 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.
12. Bleeding diathesis due to underlying medical condition or ongoing anticoagulation
medication.
13. 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.
14. Active infection requiring systemic treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Aruna Parikh
Email:
arparikh@coh.org
Contact backup:
Last name:
Dan Li, MD
Facility:
Name:
Emory Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Emma Barton-Judson
Email:
ejudson@emory.edu
Contact backup:
Last name:
Mehmet Bilen, MD
Facility:
Name:
Northwestern
Address:
City:
Chicago
Zip:
60208
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jamila Juzer
Email:
jamila.juzer@northwestern.edu
Contact backup:
Last name:
Devalingam Mahalingam, MD
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paige Burkard
Email:
Paige.Burkard@roswellpark.org
Contact backup:
Last name:
Christos Fountzilas, MD
Facility:
Name:
University of Cincinnati
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melanie Margraf
Email:
margrame@ucmail.uc.edu
Contact backup:
Last name:
Jennifer Leddon
Facility:
Name:
University of Pittsburgh Medical Center
Address:
City:
Pittsburgh
Zip:
15219
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kimberly Tyberg
Email:
sheridankj@upmc.edu
Contact backup:
Last name:
Jason Luke, MD
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Li Li
Email:
LLi8@mdanderson.org
Contact backup:
Last name:
Anthony Conley
Start date:
October 2, 2023
Completion date:
May 2029
Lead sponsor:
Agency:
Imugene Limited
Agency class:
Industry
Source:
Imugene Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06063317
http://www.imugene.com/
