Cancer-Killing virus and immune drug combo tested in advanced tumors – study halted early
NCT ID NCT06063317
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tested a new treatment for adults with advanced solid tumors that had not responded to standard therapies. The treatment combined a cancer-killing virus (onCARlytics) with an immune-boosting drug (blinatumomab), given either into the tumor or through a vein. The study aimed to check safety and find the best dose, but it was terminated early, so only limited safety data were collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- onCARlytics (CF33-CD19) and blinatumomab
- What this could lead to
- If successful, this approach could point toward a new way to treat advanced solid tumors by using a virus to target cancer cells and an immune therapy to boost the body's attack.
- What could go wrong
- This was a very early (Phase 1) study that was terminated, so results are limited. The combination may cause serious side effects, and it is unknown if it will shrink tumors or improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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25 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Feb 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope
Duarte, California, 91010, United States
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Emory Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Northwestern
Chicago, Illinois, 60208, United States
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Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203, United States
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University of Cincinnati
Cincinnati, Ohio, 45219, United States
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University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219, United States
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