Phase
Condition
Neoplasms
Treatment
CF33-CD19 IT
Blinatumomab
CF33-CD19 IV Combination
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 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.
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, laboratorytests, and other study procedures.
Exclusion
Exclusion Criteria:
Prior treatment with a poxvirus based oncolytic virus or a bispecific CD19-directedCD3 T-cell engager.
Continuous systemic treatment with either corticosteroids (>10 mg daily prednisoneequivalents) or other immunosuppressive medications within 4 weeks prior to firstdose 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 requiredsteroids or has current pneumonitis / interstitial lung disease.
History of pancreatitis.
Prior allogeneic tissue/organ transplant or other medical conditions requiringongoing treatment with immunosuppressive drugs or any condition resulting in asystemic immunosuppressed state.
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.
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.
Bleeding diathesis due to underlying medical condition or ongoing anticoagulationmedication.
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.
Active infection requiring systemic treatment.
Study Design
Study Description
Connect with a study center
City of Hope
Duarte, California 91010
United StatesSite Not Available
City of Hope
Duarte 5344147, California 5332921 91010
United StatesSite Not Available
Emory Winship Cancer Institute
Atlanta, Georgia 30322
United StatesSite Not Available
Emory Winship Cancer Institute
Atlanta 4180439, Georgia 4197000 30322
United StatesSite Not Available
Northwestern
Chicago, Illinois 60208
United StatesSite Not Available
Northwestern
Chicago 4887398, Illinois 4896861 60208
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198
United StatesSite Not Available
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14203
United StatesSite Not Available
Roswell Park Comprehensive Cancer Center
Buffalo 5110629, New York 5128638 14203
United StatesSite Not Available
University of Cincinnati
Cincinnati, Ohio 45219
United StatesSite Not Available
University of Cincinnati
Cincinnati 4508722, Ohio 5165418 45219
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15219
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh 5206379, Pennsylvania 6254927 15219
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available

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