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Monoclonal Antibodies

TLR9 Agonist + Anti-OX40 Antibody + Radiation for Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Ronald Levy

Eligibility Criteria Checklist

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

Must have

Biopsy confirmed low-grade B-cell lymphoma, excluding gastric MALT lymphoma, high-risk mantle cell lymphoma, and currently transformed lymphoma

Patients must have at least one site of disease that is accessible for intratumoral injection of SD-101 (diameter ≥10mm) percutaneously and presents a low risk for complications from direct injections

Must not have

Known history of human immunodeficiency virus (HIV) or active hepatitis C virus or active hepatitis B virus infection or any uncontrolled active systemic infection

Currently transformed lymphoma, high-risk mantle cell lymphoma, or gastric MALT lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 96 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of an antibody when given with a TLR9 agonist and radiation therapy for low-grade B-cell NHL.

Who is the study for?

This trial is for adults with certain types of low-grade B-cell Non-Hodgkin lymphomas, excluding some specific subtypes. Participants must have a tumor suitable for direct injection and be in good general health (ECOG 0 or 1). They should not have had recent cancer treatments and must practice effective birth control. People with autoimmune diseases, other cancers within the last two years, significant heart issues, or active infections are excluded.

What is being tested?

The study tests combining SD-101 (a TLR9 agonist that may boost the immune system), an anti-OX40 antibody (BMS-986178) that could enhance T cell activation to fight tumors, and radiation therapy which kills cancer cells. The goal is to find out if this combination works better together than current treatments.

What are the potential side effects?

Possible side effects include reactions at the injection site, flu-like symptoms from immune stimulation by SD-101, allergic reactions to BMS-986178 similar to other monoclonal antibodies, fatigue from radiation therapy as well as potential increased risk of infection due to overall immune system activation.

Eligibility Criteria

Inclusion Criteria

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

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My biopsy shows I have low-grade B-cell lymphoma, not including specific types.

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I have a tumor that can be safely injected and is at least 10mm big.

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I have a tumor that can be measured and is not being treated with radiation.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My kidneys are functioning well enough (creatinine clearance over 25 ml/min).

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I am not pregnant or breastfeeding and have a negative pregnancy test.

Exclusion Criteria

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

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I do not have HIV, active hepatitis B or C, or any uncontrolled infection.

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My condition is a specific type of advanced lymphoma.

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I need treatment right away to reduce my cancer.

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I don't have a safe spot for an injection.

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I have been treated for an autoimmune disease like lupus or rheumatoid arthritis in the last 5 years.

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I have not had major surgery in the last 4 weeks and my wounds are fully healed.

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I have been diagnosed with lymphoma in my brain or spinal cord.

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I do not have serious heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 96 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 96 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 96 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants experiencing Dose-limiting Toxicities (DLT) within 8 weeks of treatment initiation

Secondary study objectives

Overall Response Rate (ORR)

Progression-Free Survival (PFS)

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: Treatment (radiation therapy, SD-101, BMS-986178)Experimental Treatment4 Interventions

Patients receive radiation therapy on days 1-2, TLR9 agonist SD-101 and anti-OX40 antibody BMS-986178 intratumorally on days 2, 9, 16, 23, and 30, and anti-OX40 antibody BMS-986178 IV on days 2, 30, 58, 86, 114, and 142 in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Anti-OX40 Antibody BMS 986178

2018

Completed Phase 1

~30