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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 96 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants experiencing Dose-limiting Toxicities (DLT) within 8 weeks of treatment initiation
Secondary outcome measures
Overall Response Rate (ORR)
Progression-Free Survival (PFS)

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
Anti-OX40 Antibody BMS 986178
2019
Completed Phase 1
~20
Radiation Therapy
2017
Completed Phase 3
~7250
TLR9 Agonist SD-101
2016
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Ronald LevyLead Sponsor
4 Previous Clinical Trials
131 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,631 Total Patients Enrolled

Media Library

Anti-OX40 Antibody BMS 986178 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03410901 — Phase 1
Follicular Lymphoma Research Study Groups: Treatment (radiation therapy, SD-101, BMS-986178)
Follicular Lymphoma Clinical Trial 2023: Anti-OX40 Antibody BMS 986178 Highlights & Side Effects. Trial Name: NCT03410901 — Phase 1
Anti-OX40 Antibody BMS 986178 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03410901 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the uppermost participant limit of this trial?

"Unfortunately, this trial is not currently taking in new candidates. The status was last updated on May 3rd 2022 and the listing first appeared April 9th 2018. If you are seeking similar studies, there are 1936 clinical trials actively recruiting patients with mantle cell lymphoma (mcl) and 2 additional programs that use radiation therapy to treat mcl."

Answered by AI

Is there capacity for new participants in this clinical trial?

"This research endeavor is temporarily closed to recruitment. It was initially posted on April 9th, 2018 and most recently amended on May 3rd 2022. During this period there are 1936 clinical trials for mantle cell lymphoma (mcl) actively seeking volunteers, as well 2 Radiation Therapy studies that require candidates."

Answered by AI

How has Radiation Therapy been explored in past clinical research endeavors?

"At the moment, two research initiatives into radiation therapy are currently underway. None of these experiments have progressed to Phase 3 status yet. Additionally, while most trials for this treatment take place in Palo Alto, California there are 2 other medical locations running tests too."

Answered by AI

What is the regulatory status of radiation therapy in terms of safety and efficacy?

"As this is a Phase 1 study, with limited evidence of efficacy and safety, Radiation Therapy was assigned the lowest score on our scale - a 1."

Answered by AI
~1 spots leftby Oct 2024