TLR9 Agonist SD-101, Ibrutinib, and Radiation Therapy in Treating Patients With Relapsed or Refractory Grade 1-3A Follicular Lymphoma
Summary
This phase Ib/II trial studies the side effects and best dose of toll-like receptor 9 (TLR9) agonist SD-101 when given together with ibrutinib and radiation therapy and to see how well they work in treating patients with Low Grade Follicular Lymphoma, Marginal Zone Lymphoma, or Mantle Cell Lymphoma that has come back after a period of improvement or no longer responds to treatment. Immunostimulants such as TLR9 agonist SD-101 may increase the ability of the immune system to fight infection and disease. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving TLR9 agonist SD-101 with ibrutinib and radiation therapy may induce an immune response and prolong anti-tumor response.
Timeline
- Start
- 2016-11-07
- Primary completion
- 2023-05-18
- Completion
- 2023-05-18
Publications
- Shree T, Haebe S, Czerwinski DK, Eckhert E, Day G, Sathe A, Grimes S, Frank MJ, Maeda LS, Alizadeh AA, Advani R, Hoppe RT, Long SR, Martin B, Ozawa MG, Khodadoust MS, Ji HP, Levy R. A clinical trial of therapeutic vaccination in lymphoma with serial tumor sampling and single-cell analysis. Blood Adv. 2024 Jan 9;8(1):130-142. doi: 10.1182/bloodadvances.2023011589.
- Mooney KL, Czerwinski DK, Shree T, Frank MJ, Haebe S, Martin BA, Testa S, Levy R, Long SR. Serial FNA allows direct sampling of malignant and infiltrating immune cells in patients with B-cell lymphoma receiving immunotherapy. Cancer Cytopathol. 2022 Mar;130(3):231-237. doi: 10.1002/cncy.22531. Epub 2021 Nov 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nelitolimod | Oligonucleotide (other) | 3 mg | Intrathecal |
| Background | Ibrutinib | Small molecule | — | Oral |