AzTrials
AzTrials

Solid Tumor, AdultPhase 1OASISNCT06063317

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

A Phase 1 study testing CF33-CD19 IT Monotherapy, CF33-CD19 IV Monotherapy and CF33-CD19 IT Combination in people with Solid Tumor, Adult, run by Imugene Limited at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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 and with or without hydroxyurea in adults with advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Adult
What is being tested?
CF33-CD19 IT Monotherapy, CF33-CD19 IV Monotherapy and CF33-CD19 IT Combination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
8 sitesUnited States
Study dates
2 Oct 2023to 2 Feb 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
  • At least one measurable lesion as defined by RECIST v1.1 criteria.
Show all 10Show fewer
  • Adequate renal function.
  • Adequate hepatic function.
  • Adequate hematologic function.
  • Willing and able to comply with scheduled visits, study treatment plan, laboratory tests, and other study procedures.

Who cannot join

  • Prior treatment with a poxvirus based oncolytic virus or a bispecific CD19-directed CD3 T-cell engager.
  • 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.
  • 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 required steroids or has current pneumonitis / interstitial lung disease.
Show all 13Show fewer
  • History of pancreatitis.
  • Prior allogeneic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state.
  • 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.
  • 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.
  • Bleeding diathesis due to underlying medical condition or ongoing anticoagulation medication.
  • 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.
  • Active infection requiring systemic treatment.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14203

  • Northwestern

    Chicago, Illinois, 60208

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • City of Hope

    Duarte, California, 91010

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15219

Other trials in United States

About this study

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)

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.

Read the detailed description

CF33-CD19, a novel chimeric orthopoxvirus, will be administered as a monotherapy or in combination with blinatumomab and with or without hydroxyurea 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.

Being tested
CF33-CD19 IT Monotherapy, CF33-CD19 IV Monotherapy, CF33-CD19 IT Combination, CF33-CD19 IV Combination, Blinatumomab
Keywords
Immunotherapy, Oncolytic Virus, Bispecific T-Cell Engager, BiTE, Blincyto
Medical subject headings
Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CF33-CD19 IT MonotherapyBiological

    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.

  • CF33-CD19 IV MonotherapyBiological

    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.

  • CF33-CD19 IT CombinationBiological

    Dose Escalation Combination Phase: CF33-CD19 will be administered intratumorally on Days 1 and 15 of each 28 day cycle.

  • CF33-CD19 IV CombinationBiological

    Dose Escalation Combination Phase: CF33-CD19 will be administered intravenously on Days 1 and 15 of each 28 day cycle.

  • BlinatumomabDrug

    Blinatumomab will be infused via a 7-day continuous infusion from Days 2-9 and Days 16-23 of each 28-day cycle.

  • HydroxyureaDrug

    Hydroxyurea will be orally administered daily.

Study groups in NCT06063317
Study groupRoleWhat they receive
CF33-CD19 IT Administration MonotherapyExperimentalNot described
Receives: Biological: CF33-CD19 IT Monotherapy
CF33-CD19 IV Administration MonotherapyExperimentalNot described
Receives: Biological: CF33-CD19 IV Monotherapy
CF33-CD19 IT Administration in Combination with BlinatumomabExperimentalNot described
Receives: Biological: CF33-CD19 IT Combination; Drug: Blinatumomab
CF33-CD19 IV Administration in Combination with BlinatumomabExperimentalNot described
Receives: Biological: CF33-CD19 IV Combination; Drug: Blinatumomab
CF33-CD19 IT Administration in Combination with Blinatumomab and HydroxyureaExperimentalNot described
Receives: Biological: CF33-CD19 IT Combination; Drug: Blinatumomab; Drug: Hydroxyurea
CF33-CD19 IV Administration in Combination with Blinatumomab and HydroxyureaExperimentalNot described
Receives: Biological: CF33-CD19 IV Combination; Drug: Blinatumomab; Drug: Hydroxyurea

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All Treatment Arms - Incidence and severity of Adverse Events

    Adverse events will be graded according to CTCAE v5.0.

    Measured: From first dose of study drug through 30 days following the last dose of study treatment

  2. Monotherapy Treatment Arms - Determination of the Recommended Phase 2 Dose (RP2D) to apply to Dose Escalation Combination Phase as supported by immune response as seen in lymphocyte subsets

    Change in lymphocyte subset expression in tumor tissue and peripheral blood pre and post dose

    Measured: From first dose of study drug through treatment discontinuation, an average of 6 months

  3. Monotherapy Treatment Arms - Determination of RP2D to apply to Dose Escalation Combination Phase as supported by immune response as seen in cytokines

    Change in cytokine levels in peripheral blood pre and post dose

    Measured: From first dose of study drug through treatment discontinuation, an average of 6 months

  4. Monotherapy Treatment Arms - Determination of RP2D to apply to Dose Escalation Combination Phase as supported by anti-tumor activity

    Stable Disease and Response (PR and CR) based on RECIST v1.1 and iRECIST v1.0.

    Measured: From first dose of study drug through treatment discontinuation, an average of 6 months

Secondary outcomes (7)

  1. Combination Treatment Arms - Determination of the Recommended Phase 2 Dose (RP2D) for CF33-CD19 + blinatumomab + hydroxyurea combination as supported by immune response as seen in lymphocyte subsets

    Change in lymphocyte subset expression in tumor tissue and peripheral blood pre and post dose

    Measured: From first dose of study drug through treatment discontinuation, an average of 6 months

  2. Combination Treatment Arms - Determination of RP2D for CF33-CD19 + blinatumomab + hydroxyurea combination as supported by immune response as seen in cytokines

    Change in cytokine levels in peripheral blood pre and post dose

    Measured: From first dose of study drug through treatment discontinuation, an average of 6 months

  3. Combination Treatment Arms - Determination of RP2D for CF33-CD19 + blinatumomab + hydroxyurea combination as supported by anti-tumor activity

    Stable Disease and Response (PR and CR) based on RECIST v1.1 and iRECIST v1.0.

    Measured: From first dose of study drug through treatment discontinuation, an average of 6 months

  4. All Treatment Arms - Overall Response Rate

    Overall Response Rate (ORR) is defined as the proportion of subjects in the efficacy population who achieve a radiographic Investigator-assessed confirmed CR or PR, per RECIST v1.1 or confirmed iCR or iPR per iRECIST v1.0.

    Measured: From first dose of study drug through treatment discontinuation, an average of 6 months

  5. All Treatment Arms - Progression Free Survival

    Progression Free Survival (PFS) defined as the time from first dose of study drug to first documentation of PD based on RECIST 1.1, or to death from any cause.

    Measured: From first dose of study drug through treatment discontinuation, an average of 6 months

  6. All Treatment Arms - Duration of Response

    Duration of Response (DoR) measured as the time from the date a response of PR/iPR or better was first recorded to the date on which progressive disease was first noted or the date of death due to any cause.

    Measured: From first dose of study drug through treatment discontinuation, an average of 6 months

  7. All Treatment Arms - Disease Control Rate

    Disease Control Rate (DCR), measured as the proportion of subjects who achieve an Investigator-assessed confirmed CR/iCR, PR/iPR, or Stable Disease (SD)/immune SD (iSD) per RECIST v1.1 and iRECIST v1.0.

    Measured: From first dose of study drug through treatment discontinuation, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2023
  2. Study start2 Oct 2023
  3. Primary completion2 Feb 2026
  4. Study completion2 Feb 2026

Why it stopped: Portfolio prioritization

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06063317
Sponsor's protocol ID
CF33-CD19-101
Acronym
OASIS
Status last verified
Dec 2025
First submitted
14 Sep 2023
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CF33-CD19 IT Monotherapy, CF33-CD19 IV Monotherapy and CF33-CD19 IT Combination in people with Solid Tumor, Adult, run by Imugene Limited at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Portfolio prioritization). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All Treatment Arms - Incidence and severity of Adverse Events (time frame: From first dose of study drug through 30 days following the last dose of study treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06063317.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in