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NCT03410901 · ClinicalTrials.gov registry record · Phase 1
TLR9 Agonist SD-101, Anti-OX40 Antibody BMS 986178, and Radiation Therapy in Treating Patients With Low-Grade B-Cell Non-Hodgkin Lymphomas
A Phase 1 study, sponsored by Ronald Levy.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT03410901: Completed Phase 1 study, sponsored by Ronald Levy.
NCT03410901 is a Phase 1 study that has completed, run by Ronald Levy. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03410901, a Phase 1 study, has completed, sponsored by Ronald Levy.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of the anti-OX40 antibody BMS-986178 when given together with the TLR9 agonist SD-101 and radiation therapy in treating patients with low-grade B-cell Non-Hodgkin lymphomas. TLR9 agonist SD-101 may stimulate the immune system in different ways and stop cancer cells from growing. Anti-OX40 antibody is a monoclonal antibody that enhances the activation of T cells, immune cells that are important for fighting tumors Radiation therapy uses high energy x-rays to kill cancer cells and may make them more easily detected by the immune system. Giving TLR9 agonist SD-101 together with anti-OX40 antibody BMS 986178 and radiation therapy may work better in treating patients with low-grade B-cell non-hodgkin lymphomas.
Primary Outcome
Dose-limiting toxicities (DLTs) as assessed as the following hematologic toxicities (grades per CTCAE) in all participants receiving at least 1 intratumoral (IT) injection of SD-101 and at least 1 dose of BMS-986178 (not including events due to disease progression or definitively unrelated to study drugs): * Febrile neutropenia * Thrombocytopenia Grade 4 or Grade 3 with bleeding or platelet transfusion * Anemia Grade 4 * Non-hematological toxicity ≥ grade 3, except: * Alopecia controlled by
Interventions
- OTHER Laboratory Biomarker Analysis
- RADIATION Radiation Therapy
- BIOLOGICAL Anti-OX40 Antibody BMS 986178
- DRUG TLR9 Agonist SD-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-04-09 |
| Est. Completion | 2024-10-10 |
| Phase | Phase 1 |
What the finished NCT03410901 record still lists
NCT03410901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03410901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03410901 about?
NCT03410901 is a clinical study titled "TLR9 Agonist SD-101, Anti-OX40 Antibody BMS 986178, and Radiation Therapy in Treating Patients With Low-Grade B-Cell Non-Hodgkin Lymphomas". This phase I trial studies the side effects and best dose of the anti-OX40 antibody BMS-986178 when given together with the TLR9 agonist SD-101 and radiation therapy in treating patients with low-grade B-cell Non-Hodgkin lymphomas. TLR9 agonist SD-101 may stimulate the immune system in different way...
What is the current status of trial NCT03410901?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2018-04-09. Estimated completion is 2024-10-10.
What interventions are being tested in trial NCT03410901?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Radiation Therapy (RADIATION), Anti-OX40 Antibody BMS 986178 (BIOLOGICAL), TLR9 Agonist SD-101 (DRUG).
Who is sponsoring clinical trial NCT03410901?
This trial is sponsored by Ronald Levy, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03410901's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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