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Monoclonal Antibodies
CF33-CD19 + Blinatumomab for Solid Cancers (OASIS Trial)
Phase 1
Recruiting
Research Sponsored by Imugene Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Any histologically or cytologically confirmed advanced or metastatic solid tumor with documented radiological progression per RECIST v1.1 following at least one prior line of treatment. 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
Must not have
History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease
History of pancreatitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug through treatment discontinuation, an average of 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new virus and an immune-boosting drug in adults with advanced cancers that haven't responded to other treatments. The virus aims to kill cancer cells directly, while the drug helps the immune system attack the cancer.
Who is the study for?
Adults over 18 with advanced or metastatic solid tumors that have worsened after at least one treatment line, including targeted therapies. Participants must be in good physical condition (ECOG 0-1), have a measurable lesion, proper organ function, and a life expectancy of over 3 months. Excluded are those on high-dose steroids or immunosuppressants, recent radiation therapy recipients, certain heart conditions, active infections or autoimmune diseases, severe skin disease with open wounds, lung issues requiring steroids, history of pancreatitis or significant neuropathy.
What is being tested?
The trial is testing the safety and effectiveness of CF33-CD19 given through IV or directly into the tumor combined with blinatumomab for treating solid tumors. It's an early-phase study where doses will gradually increase to find the safest amount that can be given.
What are the potential side effects?
Potential side effects may include typical reactions from immune-based cancer treatments such as flu-like symptoms (fever, chills), fatigue; infusion-related reactions; possible organ inflammation due to immune activation; and local site reaction if injected directly into the tumor.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced cancer has worsened after treatment, and I've had at least two prior treatments.
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or had lung inflammation that needed steroids.
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I have had pancreatitis before.
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I do not have severe numbness or pain in my hands or feet.
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I have a serious heart condition, such as heart failure or uncontrolled high blood pressure.
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I have had an organ transplant or need medicine that weakens my immune system.
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I have not had radiation in the last 2 weeks.
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I am currently being treated for an infection.
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I have been treated with a virus or a dual-targeting T-cell therapy.
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I have or had severe skin disease with open wounds.
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I have or had brain or CNS cancer spread.
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I have a bleeding disorder or am on blood thinners.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of study drug through treatment discontinuation, an average of 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug through treatment discontinuation, an average of 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
All Treatment Arms - Incidence and severity of Adverse Events
Monotherapy Treatment Arms - Determination of RP2D to apply to Dose Escalation Combination Phase as supported by anti-tumor activity
Monotherapy Treatment Arms - Determination of RP2D to apply to Dose Escalation Combination Phase as supported by immune response as seen in cytokines
+1 moreSecondary study objectives
All Treatment Arms - Disease Control Rate
All Treatment Arms - Duration of Response
All Treatment Arms - Overall Response Rate
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: CF33-CD19 IV Administration in Combination with BlinatumomabExperimental Treatment2 Interventions
Group II: CF33-CD19 IV Administration MonotherapyExperimental Treatment1 Intervention
Group III: CF33-CD19 IT Administration in Combination with BlinatumomabExperimental Treatment2 Interventions
Group IV: CF33-CD19 IT Administration MonotherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinatumomab
2014
Completed Phase 3
~1230
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The treatment of solid tumors often involves innovative approaches such as oncolytic viruses and bispecific T-cell engagers. Oncolytic viruses like CF33-CD19 selectively infect and kill cancer cells while sparing normal cells, and they can also stimulate an anti-tumor immune response.
CF33-CD19 specifically targets CD19, a protein expressed on the surface of certain cancer cells, enhancing the virus's ability to destroy these cells. Blinatumomab, a bispecific T-cell engager, works by binding to both T-cells and cancer cells, bringing them into close proximity to facilitate the T-cells' ability to attack and kill the cancer cells.
This dual mechanism is particularly important for solid tumor patients as it not only directly targets and kills cancer cells but also harnesses the body's immune system to fight the tumor, potentially leading to more effective and sustained anti-tumor responses.
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Who is running the clinical trial?
Imugene LimitedLead Sponsor
6 Previous Clinical Trials
305 Total Patients Enrolled
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