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Cancer-Killing virus and immune drug combo tested in advanced tumors – study halted early

NCT ID NCT06063317

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

25 people

The number who actually took part.

Started

Oct 2023

Finished

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

Anyone

Healthy volunteers

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

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

  • City of Hope

    Duarte, California, 91010, United States

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Northwestern

    Chicago, Illinois, 60208, United States

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14203, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15219, United States

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