What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly those involving oncolytic viruses like CF33-CD19 and bispecific T-cell engagers like Blinatumomab, include flu-like symptoms (fever, chills, fatigue), injection site reactions, and gastrointestinal issues (nausea, vomiting, diarrhea). Additionally, patients may experience immune-related adverse effects such as cytokine release syndrome, which can cause fever, low blood pressure, and difficulty breathing. Hematologic toxicities, including neutropenia and anemia, are also common. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of solid tumors, though specific approvals for combinations like an oncolytic virus targeting CD19 and a bispecific T-cell engager are limited. Oncolytic viruses, such as talimogene laherparepvec (T-VEC), have been approved for melanoma, while bispecific T-cell engagers like blinatumomab are primarily approved for hematologic malignancies such as acute lymphoblastic leukemia. Other immunotherapies, including immune checkpoint inhibitors like pembrolizumab and nivolumab, have been approved for various solid tumors, including melanoma, lung cancer, and renal cell carcinoma. These therapies work by enhancing the body's immune response against cancer cells.

What other types of research exist?

Promising novel alternatives for solid tumor patients in 2024 include: 1) Pembrolizumab (an immune checkpoint inhibitor) combined with other agents like chemotherapy or targeted therapies, 2) Nivolumab plus Ipilimumab (combination of two immune checkpoint inhibitors), 3) Talimogene laherparepvec (T-VEC) combined with Pembrolizumab, and 4) Atezolizumab plus Bevacizumab (combination of an immune checkpoint inhibitor and an anti-angiogenic agent). These therapies have shown efficacy in various solid tumors and are being actively studied in clinical trials.

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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug through treatment discontinuation, an average of 6 months for reporting.

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 more

Secondary study objectives

All Treatment Arms - Disease Control Rate

All Treatment Arms - Duration of Response

All Treatment Arms - Overall Response Rate

+4 more

Awards & 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

0 / 13Eligibility criteria met

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.