TLR9 Agonist SD-101, Anti-OX40 Antibody BMS 986178, and Radiation Therapy in Treating Patients With Low-Grade B-Cell Non-Hodgkin Lymphomas
NCT03410901 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2024-12-11
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.
Conditions
- B-Cell Non-Hodgkin Lymphoma
- Grade 1 Follicular Lymphoma
- Grade 2 Follicular Lymphoma
- Grade 3a Follicular Lymphoma
- Lymphoplasmacytic Lymphoma
- Mantle Cell Lymphoma
- Marginal Zone Lymphoma
- Small Lymphocytic Lymphoma
Interventions
- BIOLOGICAL
-
Anti-OX40 Antibody BMS 986178
Given IV, intratumoral
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- RADIATION
-
Radiation Therapy
Undergo radiation therapy
- DRUG
-
TLR9 Agonist SD-101
Given intratumorally
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Ronald Levy
lead OTHER
Principal Investigators
-
Ronald Levy · Stanford University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-09
- Primary Completion
- 2024-10-09
- Completion
- 2024-10-10
- FDA Drug
- Yes
Countries
- United States
Study Locations
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