ACTIVE_NOT_RECRUITING

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

Conditions

Solid Tumor, Adult Immunotherapy Oncolytic Virus Bispecific T-Cell Engager BiTE Blincyto

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I, Dose Escalation and Dose Expansion, Safety and Tolerability Study of onCARlytics (CF33-CD19), Administered Intravenously or Intratumorally in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS)

Quick Facts

Study Start:2023-10-02

Study Completion:2029-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06063317

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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. Prior allogeneic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state. 9. 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. 10. 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. 11. Bleeding diathesis due to underlying medical condition or ongoing anticoagulation medication. 12. 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. 13. Active infection requiring systemic treatment.

Inclusion Criteria

Exclusion 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.

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. Prior allogeneic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state.
9. 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.
10. 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.
11. Bleeding diathesis due to underlying medical condition or ongoing anticoagulation medication.
12. 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.
13. Active infection requiring systemic treatment.

Contacts and Locations

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

Emory Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Northwestern

Chicago, Illinois, 60208

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203

United States

University of Cincinnati

Cincinnati, Ohio, 45219

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Imugene Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-02

Study Completion Date2029-05

Study Record Updates

Study Start Date2023-10-02

Study Completion Date2029-05

Terms related to this study

Keywords Provided by Researchers

Immunotherapy
Oncolytic Virus
Bispecific T-Cell Engager
BiTE
Blincyto

Additional Relevant MeSH Terms

Solid Tumor, Adult