Trial Search Results

TLR9 Agonist SD-101, Ibrutinib, and Radiation Therapy in Treating Patients With Relapsed or Refractory Grade 1-3A Follicular Lymphoma

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 grade 1-3a follicular 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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Robert Lowsky

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):


  • Drug: Ibrutinib
  • Other: Laboratory Biomarker Analysis
  • Radiation: Radiation Therapy
  • Drug: TLR9 Agonist SD-101


Phase 1/Phase 2


Inclusion Criteria:

   - Biopsy confirmed grade 1 or 2, or 3A follicular lymphoma; patients must have relapsed
   from or are refractory to prior therapy

   - Patients must have at least one site of disease that is accessible for intratumoral
   injection of SD-101 (diameter >= 10 mm), percutaneously

   - Tumor specimens must be available for immunological studies either from a previous
   biopsy or a new biopsy obtained before the initiation of the study

   - Patients must have at least one site of measurable disease other than the injection
   site which is not included in the radiation field

   - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

   - Absolute neutrophil count (ANC) >= 1000/mm^3 independent of growth factor support

   - Platelets: >= 100,000/mm^3 or >= 50,000/mm^3 if bone marrow involvement independent of
   transfusion support in either situation

   - Hemoglobin: >= 8 g/dL (may be transfused)

   - Creatinine clearance > 25 ml/min

   - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT): =< 3 x ULN

   - Bilirubin: =< 1.5 x ULN (except for subjects with Gilbert's syndrome or of non-hepatic

   - Must be at least 4 weeks since treatment with standard or investigational
   chemotherapy, biochemotherapy, surgery, radiation, cytokine therapy, and 8 weeks since
   any monoclonal antibodies or immunotherapy, and recovered from any clinically
   significant toxicity experienced during treatment

   - Women of childbearing potential and men who are sexually active must be practicing a
   highly effective method of birth control during and after the study consistent with
   local regulations regarding the use of birth control methods for subjects
   participating in clinical trials; men must agree to not donate sperm during and after
   the study; for females, these restrictions apply for 1 month after the last dose of
   study drug; for males, these restrictions apply for 3 months after the last dose of
   study drug

   - Women of childbearing potential must have a negative serum (beta-human chorionic
   gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant
   or breastfeeding are ineligible for this study

   - Life expectancy greater than 4 months

   - Able to comply with the treatment schedule

   - Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

   - Autoimmune disease including systemic lupus erythematosus, rheumatoid arthritis,
   multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, history of
   uveitis, or other if clinically significant

   - Major surgery or a wound that has not fully healed within 4 weeks of enrollment

   - History of stroke or intracranial hemorrhage within 6 months prior to enrollment

   - Requires anticoagulation with warfarin or equivalent vitamin K antagonists

   - Requires chronic treatment with strong cytochrome P450 family 3, subfamily A,
   polypeptide 4 (CYP3A4) inhibitors

   - Vaccinated with live, attenuated vaccines within 4 weeks of enrollment

   - Known history of human immunodeficiency virus (HIV) or active hepatitis C virus or
   active hepatitis B virus infection or any uncontrolled active systemic infection

   - Patients with active infection or with a fever > 38.50 degrees Celsius (C) within
   three days prior to the first scheduled treatment

   - Known central nervous system (CNS) lymphoma

   - Patients with a history of prior malignancy with the exception of non-melanoma skin
   cancer, carcinoma in situ of the cervix, in situ carcinoma of the bladder, or other
   malignancy diagnosed > 5 years ago that has undergone potentially curative therapy
   with no evidence of disease for the last > 5 years and that is deemed by the
   investigator to be a low risk for recurrence

   - History of allergic reactions attributed to compounds of similar composition to SD-101
   or ibrutinib

   - Treatment with an immunosuppressive regimen of corticosteroids or other
   immunosuppressive medication (e.g., methotrexate, rapamycin) within 30 days of study
   treatment; Note: patients with adrenal insufficiency may take up to 5 mg of prednisone
   or equivalent daily; topical and inhaled corticosteroids in standard doses are allowed

   - Significant cardiovascular disease (i.e. New York Heart Association [NYHA] class 3
   congestive heart failure; myocardial infarction with the past 6 months; unstable
   angina; coronary angioplasty with the past 6 months; uncontrolled atrial or
   ventricular cardiac arrhythmias)

   - Pregnant or breast feeding

   - Any other medical history, including laboratory results, deemed by the investigator to
   be likely to interfere with their participation in the study, or to interfere with the
   interpretation of the results

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Destiny Phillips