What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, such as the CHOP regimen (cyclophosphamide, doxorubicin, vincristine, and prednisone) and targeted therapies like rituximab, have well-documented side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, increased risk of infections, and neuropathy. Doxorubicin is particularly known for its potential cardiotoxicity. Rituximab, a monoclonal antibody, can lead to infusion-related reactions, including fever, chills, and low blood pressure, as well as increased risk of infections. Long-term side effects may include secondary cancers and persistent neuropathy.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma (NHL), including monoclonal antibodies like rituximab, which targets the CD20 protein on B cells, and CAR-T cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, which modify a patient's T cells to target CD19 on B cells. Additionally, small molecule inhibitors like ibrutinib, which inhibits Bruton's tyrosine kinase, have been approved for certain subtypes of NHL. These therapies represent a range of mechanisms aimed at targeting specific proteins or pathways involved in the proliferation of lymphoma cells.

What other types of research exist?

Promising novel alternatives to ONO-7018 for Non-Hodgkin's Lymphoma patients could include TLR2/4 receptor agonists like OM-174, which have shown potential in reducing tumor progression and enhancing the efficacy of chemotherapy. Additionally, prodrugs like oncrasin-266, which improve stability and pharmacokinetics of their active compounds, may also be considered for their enhanced therapeutic profiles.

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Monoclonal Antibodies

ONO-7018 for Non-Hodgkin's Lymphoma and Chronic B-Cell Leukemia

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

Be older than 18 years old

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 is testing ONO-7018, a new drug designed to treat certain blood cancers that have not responded to other treatments. It works by blocking a protein that cancer cells need to grow. The study aims to find the best dose and check the drug's safety and effectiveness.

Who is the study for?

This trial is for adults over 18 with certain types of blood cancers (NHL or CLL) that have come back or haven't responded to treatment, and who don't have other good treatment options. They should be fairly active (ECOG 0-2), able to swallow tablets, and not have serious medical issues that could affect the study.

What is being tested?

ONO-7018 is being tested in this first-in-human study which has two parts: finding the right dose and then seeing how well it works at that dose. It's an open-label study, meaning everyone knows they're getting ONO-7018, and it's given across multiple centers.

What are the potential side effects?

Since ONO-7018 is new, its side effects aren't fully known yet. However, participants will be closely monitored for any adverse reactions throughout the trial phases.

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 Tolerated Dose (MTD)

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

Secondary study objectives

Antitumor Activity of ONO-7018 (Duration of Response [DOR])

Antitumor Activity of ONO-7018 (Overall Response Rate [ORR])

Antitumor Activity of ONO-7018 (Overall Survival [OS])

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion Phase (Part 2)Experimental Treatment1 Intervention

Eligible patients will be assigned to the recommended dose level(s) selected from Part 1.

Group II: Dose Escalation Phase (Part 1)Experimental Treatment1 Intervention

Up to 4 dose levels will be evaluated. Eligible patients will be assigned to a dose level cohort according to a traditional 3+3 dose escalation design.

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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 most common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies, such as monoclonal antibodies (e.g., rituximab), specifically target cancer cell markers, minimizing damage to normal cells. Immunotherapy, including CAR-T cell therapy, harnesses the patient's immune system to recognize and destroy cancer cells. Understanding these mechanisms helps patients and doctors choose the most effective treatment with manageable side effects, improving outcomes and quality of life.