What is the mechanism of action of this treatment?

Targeted therapies for T-Cell Lymphoma, such as ALK inhibitors (e.g., brigatinib, lorlatinib), work by specifically targeting genetic mutations or proteins that drive cancer cell growth and survival. Immunotherapies, including checkpoint inhibitors like pembrolizumab, enhance the body's immune response against cancer cells by blocking proteins that inhibit immune activity. These treatments are crucial for T-Cell Lymphoma patients as they offer more precise and potentially effective options compared to traditional chemotherapy, often with fewer side effects. By directly targeting cancer-specific pathways or boosting the immune system, these therapies can improve outcomes and quality of life for patients.

What side effects are associated with this type of intervention?

Common treatments for T-Cell Lymphoma, particularly targeted therapies and immunotherapies similar to ONO-4685, often have side effects such as skin reactions, diarrhea, liver toxicity, and fatigue. Immunotherapies may also cause immune-related adverse events including colitis, pneumonitis, hepatitis, endocrinopathies, and skin reactions. Severe side effects can include severe immune-mediated reactions and organ-specific toxicities.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for the treatment of T-Cell Lymphoma. Notable examples include brentuximab vedotin, an antibody-drug conjugate targeting CD30, and mogamulizumab, a monoclonal antibody targeting CCR4. These treatments are designed to specifically target cancer cells, similar to the investigational drug ONO-4685 being studied for relapsed or refractory T-Cell Lymphoma.

What other types of research exist?

Promising alternatives to ONO-4685 for T-cell lymphoma patients include: 1) Pembrolizumab (PD-1 inhibitor), which has shown efficacy in various lymphomas including T-cell lymphoma. 2) Avelumab (PD-L1 inhibitor), which has demonstrated durable responses in mesothelioma and may have potential in T-cell lymphoma. 3) Brentuximab vedotin (CD30-targeted antibody-drug conjugate), approved for CD30-positive T-cell lymphomas. 4) Mogamulizumab (CCR4-targeted monoclonal antibody), approved for certain types of T-cell lymphoma. These therapies offer novel mechanisms of action and have shown promise in clinical trials.

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ONO-4685 for Lymphoma

Phase 1

Recruiting

Research Sponsored by Ono Pharmaceutical Co. Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with PTCL must have at least 1 measurable lesion

Patients with histologically or cytologically confirmed diagnosis of specific subtypes of T-cell lymphoma

Must not have

Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection

Patients not recovered to Grade 1 or stabilized from the adverse effects of any prior therapy for their malignancies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new drug called ONO-4685 in patients whose T cell Lymphoma has come back or did not respond to previous treatments. Researchers aim to see if the drug is safe, how it moves through the body, and if it helps reduce the cancer.

Who is the study for?

Adults over 18 with relapsed or refractory T cell lymphoma, who've had at least two prior treatments and have measurable disease, can join this trial. They must not be pregnant, have a central nervous system involvement, HIV, hepatitis B or C infections, recent tuberculosis infection, severe allergies to monoclonal antibodies or corticosteroids.

What is being tested?

The trial is testing ONO-4685's safety and effectiveness for patients with specific types of T cell lymphoma that haven't responded well to previous treatments. It will look at how the body processes the drug and its preliminary success in treating the cancer.

What are the potential side effects?

While specific side effects of ONO-4685 are not listed here, common ones for drugs like it include immune-related reactions, infusion-related symptoms such as fever or chills, fatigue, skin issues like rash or itching and potential liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have PTCL with at least one tumor that can be measured.

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My diagnosis is a specific type of T-cell lymphoma.

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I am able to care for myself and perform daily activities.

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I have undergone at least 2 different treatments for my condition.

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I am 18 years old or older.

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My cutaneous T-cell lymphoma can be measured for treatment response.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an active infection like HIV or hepatitis B/C.

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I still have side effects from previous cancer treatments that haven't improved.

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I have been treated with drugs that target the immune system.

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I am not pregnant or breastfeeding.

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My cancer has spread to my brain or spinal cord.

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I have been diagnosed with Adult T-cell leukemia/lymphoma.

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I have had a stem cell transplant from a donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Estimate of Maximum Tolerate Dose (MTD)

Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).

Secondary study objectives

Antitumor Activity of ONO-4685

Plasma Concentration of Anti-Drug Antibody (ADA)

Plasma Concentration of ONO-4685

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ONO-4685 monotherapyExperimental Treatment1 Intervention

Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ONO-4685

2022

Completed Phase 1

~120

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

Targeted therapies for T-Cell Lymphoma, such as ALK inhibitors (e.g., brigatinib, lorlatinib), work by specifically targeting genetic mutations or proteins that drive cancer cell growth and survival. Immunotherapies, including checkpoint inhibitors like pembrolizumab, enhance the body's immune response against cancer cells by blocking proteins that inhibit immune activity. These treatments are crucial for T-Cell Lymphoma patients as they offer more precise and potentially effective options compared to traditional chemotherapy, often with fewer side effects. By directly targeting cancer-specific pathways or boosting the immune system, these therapies can improve outcomes and quality of life for patients.