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TLR9 Agonist + Anti-OX40 Antibody + Radiation for Lymphoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I do not have HIV, active hepatitis B or C, or any uncontrolled infection.My kidneys are functioning well enough (creatinine clearance over 25 ml/min).It's been over 4 weeks since my last cancer treatment and I've recovered from major side effects.I am using or willing to use effective birth control during and after the study.I have been treated for an autoimmune disease like lupus or rheumatoid arthritis in the last 5 years.I have not had major surgery in the last 4 weeks and my wounds are fully healed.My condition is a specific type of advanced lymphoma.I need treatment right away to reduce my cancer.I don't have a safe spot for an injection.I have been diagnosed with lymphoma in my brain or spinal cord.I haven't taken strong immune system suppressing drugs in the last 30 days, except for low-dose prednisone or creams and inhalers.I do not have serious heart problems.My biopsy shows I have low-grade B-cell lymphoma, not including specific types.I have a tumor that can be safely injected and is at least 10mm big.I have a tumor that can be measured and is not being treated with radiation.I am fully active or restricted in physically strenuous activity but can do light work.My hemoglobin level is at least 8 g/dL.I have not received any live vaccines in the last 4 weeks.I am not pregnant or breastfeeding and have a negative pregnancy test.I had cancer before, but it's either fully treated, non-threatening, or not requiring current treatment.
- Group 1: Treatment (radiation therapy, SD-101, BMS-986178)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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