Solid Tumors > Blinatumomab

CF33-CD19 + Blinatumomab for Solid Cancers

(OASIS Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Imugene Limited

Must not be taking: Corticosteroids, Immunosuppressants, Anticoagulants, others

Disqualifiers: Autoimmune disease, Pneumonitis, CNS metastases, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on continuous systemic corticosteroids or other immunosuppressive medications within 4 weeks before starting the study treatment.

What data supports the effectiveness of the treatment CF33-CD19 + Blinatumomab for solid cancers?

Blinatumomab has shown effectiveness in treating certain blood cancers by engaging the body's immune cells to target and destroy cancer cells, which suggests it might help in other types of cancer as well.

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What is known about the safety of Blinatumomab (Blincyto) in humans?

Blinatumomab has been shown to be generally safe in humans, but it can cause serious side effects like cytokine release syndrome (a severe immune reaction) and neurological issues (such as seizures) in some patients, especially children with certain blood cancers.

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What makes the CF33-CD19 + Blinatumomab treatment unique for solid cancers?

This treatment is unique because it combines CF33-CD19, a novel oncolytic virus, with Blinatumomab, a bispecific T-cell engager (BiTE) that targets CD19 on cancer cells and CD3 on T-cells, to enhance the immune system's ability to attack solid tumors, a mechanism not typically used in standard treatments for solid cancers.

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Eligibility Criteria

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.

Inclusion Criteria

My advanced cancer has worsened after treatment, and I've had at least two prior treatments.

Written informed consent from subject or legally authorized representative

I am fully active or can carry out light work.

Exclusion Criteria

I haven't taken high-dose steroids or immunosuppressants in the last 4 weeks.

I have or had lung inflammation that needed steroids.

I have had pancreatitis before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CF33-CD19 monotherapy or in combination with blinatumomab. Monotherapy subjects are treated on Day 1 and 8 of Cycle 1 and then on Day 1 of each 21-day cycle. Combination regimen subjects receive CF33-CD19 on Days 1 and 15 of each 28-day cycle, with blinatumomab as a 7-day continuous infusion from Days 2-9 and Days 16-23.

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and response rates.

4 weeks

Participant Groups

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.

Group I: CF33-CD19 IV Administration in Combination with Blinatumomab Experimental Treatment 2 Interventions

Group II: CF33-CD19 IV Administration Monotherapy Experimental Treatment 1 Intervention

Group III: CF33-CD19 IT Administration in Combination with Blinatumomab Experimental Treatment 2 Interventions

Group IV: CF33-CD19 IT Administration Monotherapy Experimental Treatment 1 Intervention

Blinatumomab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Blincyto for:

• Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
• High-risk first relapse BCP-ALL

🇺🇸 Approved in United States as Blincyto for:

• Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
• First or second complete remission with minimal residual disease (MRD)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

City of Hope Duarte, CA

MD Anderson Cancer Center Houston, TX

University of Cincinnati Cincinnati, OH

Emory Winship Cancer Institute Atlanta, GA

More Trial Locations

Who Is Running the Clinical Trial?

Imugene Limited Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-term survival of patients with relapsed/refractory acute lymphoblastic leukemia treated with blinatumomab. [2021] Blinatumomab is a CD19 BiTE (bispecific T-cell engager) immuno-oncology therapy that mediates the lysis of cells expressing CD19.

2. United States pubmed.ncbi.nlm.nih.gov

Blinatumomab Nonresponse Is Associated with Poor CD19-CAR Outcome in B-ALL. [2022] Blinatumomab nonresponders have worse CD19-CAR response than responders or blinatumomab-naïve patients.

3. United States pubmed.ncbi.nlm.nih.gov

Blinatumomab, a bispecific B-cell and T-cell engaging antibody, in the treatment of B-cell malignancies. [2020] Blinatumomab (Blincyto, Amgen), a bi-specific antibody, is a first-in-class, targeted immunotherapy agent for treatment of B-cell malignancies with a novel mechanism of action which involves in-vivo engagement of the patient's T cells with CD19-expressing tumour cells. Clinical trials have demonstrated its efficacy in relapsed B-cell Acute Lymphoblastic Leukaemia (B-ALL) and B-cell Non-Hodgkin's Lymphoma including in patients who are refractory to chemotherapy. This review summarises the development and design of Blinatumomab, the outcome of clinical studies demonstrating its efficacy and how to manage the administration, practically, including relevant toxicities. We compare and contrast it to other emerging agents for treatment of B-cell malignancies.

4. United States pubmed.ncbi.nlm.nih.gov

Immunomodulatory therapy of cancer with T cell-engaging BiTE antibody blinatumomab. [2020] Severe side effects and few long-term remissions frequently limit the treatment of advanced malignant diseases. Bispecific antibodies are currently emerging as a new option for the treatment of malignant diseases, which can potentially engage all cytotoxic T cells of a patient for tumor cell lysis. Blinatumomab, a bispecific single-chain BiTE antibody construct with dual specificity for CD19 and CD3, is a front runner of this antibody class. We here summarize the current state of development of blinatumomab for the treatment of patients with B-cell non-Hodgkin's lymphoma (NHL) and B-precursor acute lymphocytic leukemia (ALL). High response rates and durable remissions are observed in first clinical trials, indicating that T cells can be potently redirected for efficient and lasting elimination of malignant cells.

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Immunoglobulin repletion during blinatumomab therapy does not reduce the rate of secondary hypogammaglobulinemia and associated infectious risk. [2022] Blinatumomab has demonstrated efficacy in minimal residual disease (MRD) positive and relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) by inciting rapid and sustained B-cell depletion.

6. United States pubmed.ncbi.nlm.nih.gov

SOHO State of the Art Updates and Next Questions | Optimal Timing of Blinatumomab for the Treatment of B-Acute Lymphoblastic Leukemia. [2023] Blinatumomab is a CD19 targeting bi-specific T-cell engager antibody construct developed for the treatment of CD19 expressing B-cell malignancies. Numerous adult and pediatric B-ALL clinical trials have demonstrated blinatumomab's efficacy in the relapse setting as well as in patients with residual disease after upfront chemotherapy. The safety profile of blinatumomab is also favorable, making it a feasible option for most patients. Several key questions remain, including the role of blinatumomab as a replacement for toxic elements of standard chemotherapy regimens in the upfront setting, its role as a bridge to hematopoietic stem cell transplantation, or whether previous blinatumomab impacts the efficacy of subsequent CAR-T cell therapy.

7. United States pubmed.ncbi.nlm.nih.gov

Blinatumomab in pediatric relapsed/refractory B-cell acute lymphoblastic leukemia: RIALTO expanded access study final analysis. [2022] The safety and efficacy of blinatumomab, a CD3/CD19-directed bispecific molecule, were examined in an open-label, single-arm, expanded access study (RIALTO). Children (>28 days and

8. Switzerland pubmed.ncbi.nlm.nih.gov

The safety of blinatumomab in pediatric patients with acute lymphoblastic leukemia: A systematic review and meta-analysis. [2022] Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that has proven efficacy in children with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). Despite its efficacy, it has also been associated with the development of potentially serious adverse events such as the cytokine release syndrome (CRS) and neurologic events. The present meta-analysis aimed to assess the safety profile of blinatumomab in terms of serious adverse events, CRS, and neurologic events (such as seizure and encephalopathy) in pediatric patients with B-cell ALL.

9. England pubmed.ncbi.nlm.nih.gov

Characterization of relapse patterns in patients with acute lymphoblastic leukemia treated with blinatumomab. [2021] Blinatumomab is a CD19/CD3 bispecific T-cell engager (BiTE) antibody that simultaneously binds CD19 on the surface of B-cells and CD3 on the surface of T-cells, resulting in tumor cell lysis. It is approved for the treatment of patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) and in patients with minimal residual disease after intensive induction chemotherapy. Relapse patterns after treatment with blinatumomab have not been well characterized.

10. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and Pharmacodynamic Relationship of Blinatumomab in Patients with Non-Hodgkin Lymphoma. [2020] Blinatumomab is a bispecific T-cell engager (BiTE®) antibody construct targeting CD3ε on T cells and CD19 on B cells. We describe the relationship between pharmacokinetics (PK) of blinatumomab and pharmacodynamic (PD) changes in peripheral lymphocytes, serum cytokines, and tumor size in patients with non-Hodgkin lymphoma (NHL).

11. United States pubmed.ncbi.nlm.nih.gov

Bispecific T-Cell Engager (BiTE) Antibody Construct Blinatumomab for the Treatment of Patients With Relapsed/Refractory Non-Hodgkin Lymphoma: Final Results From a Phase I Study. [2021] Blinatumomab is a CD19/CD3 BiTE (bispecific T-cell engager) antibody construct for the treatment of Philadelphia chromosome-negative acute B-lymphoblastic leukemia. We evaluated blinatumomab in relapsed/refractory B-cell non-Hodgkin lymphoma (NHL).