A Phase I/II Study of Intratumoral Injection of SD-101

Not Recruiting

Trial ID: NCT02254772


This phase 1-2 trial studies the side effects and best dose of ipilimumab in combination with toll-like receptor 9 (TLR9) agonist SD-101 and radiation therapy in treating patients with recurrent low-grade B-cell lymphoma.

Official Title

A Phase I/II Study of Intratumoral Injection of SD-101, an Immunostimulatory CpG, and Intratumoral Injection of Ipilimumab, an Anti-CTLA4 Monoclonal Antibody, in Combination With Local Radiation in Low-Grade B-Cell Lymphomas

Stanford Investigator(s)

Ronald Levy, MD
Ronald Levy, MD

Robert K. and Helen K. Summy Professor in the School of Medicine

Michael Khodadoust
Michael Khodadoust

Assistant Professor of Medicine (Oncology) and of Dermatology


Inclusion Criteria

   - Biopsy-confirmed low-grade B-cell lymphoma, specifically, follicular grade 1 or 2, or
   3A marginal zone or small lymphocytic 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 and of ipilimumab (diameter ≥ 10mm), 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 measurable disease other than the injection site or biopsy site

   - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 [corresponds to
   Karnofsky Performance Status (KPS) of ≥ 70]

   - White blood cell count (WBC) ≥ 2000/µL (2 x 10^9/L)

   - Absolute neutrophil count (ANC) ≥ 1000/µL (0.5 x 10^9/L)

   - Platelets ≥ 75 x 10^3/µL (75 x 10^9/L)

   - Hemoglobin ≥ 8 g/dL (may be transfused)

   - Creatinine ≤ 2.0 x upper limit of normal (ULN)

   - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 x ULN for
   subjects without liver metastasis; ≤ 5 times for liver metastases

   - Bilirubin ≤ 2.0 x ULN (except for subjects with Gilbert's Syndrome, who must have a
   total bilirubin of less than 3.0 mg/dL)

   - No active or chronic infection with human immunodeficiency virus (HIV), Hepatitis B,
   or Hepatitis C

   - 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

   - Patients of reproductive potential must agree to use an effective (> 90% reliability)
   form of contraception during the study and for 6 months following the last study drug

   - Women of reproductive potential must have negative urine pregnancy test

   - 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

   - Pre-existing autoimmune or antibody mediated disease including systemic lupus
   erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome,
   autoimmune thrombocytopenia, Addison's disease, but excluding the presence of
   auto-antibodies without clinical autoimmune disease

   - History of inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis),
   celiac disease, or other chronic gastrointestinal conditions associated with diarrhea,
   or current acute colitis of any origin

   - Any history of diverticulitis, or evidence of diverticulitis at baseline, including
   evidence limited to computed tomography (CT) scan only (note diverticulosis is not an
   exclusion criterion)

   - Severe psoriasis

   - Active thyroiditis

   - History of uveitis

   - Known history of HIV; patients with Acquired Immunodeficiency Syndrome (AIDS) are

   - Patients with active infection or with a fever > 38.5 degrees C within 3 days prior to
   the first scheduled treatment

   - Central nervous system (CNS) lymphoma

   - Prior malignancy (active within 5 years of screening) except basal cell or completely
   excised non-invasive squamous cell carcinoma of the skin, or in situ squamous cell
   carcinoma of the cervix

   - History of allergic reactions attributed to compounds of similar composition to SD-101
   or ipilimumab (anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA4] antibodies)

   - Current anticoagulant therapy (EXCEPTION acetylsalicylic acid ≤ 325 mg per day

   - Treatment with an immunosuppressive regimen of corticosteroids or other
   immunosuppressive medication (eg, 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 [ie, 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 lactating

   - 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.


biological: ipilimumab

radiation: radiation therapy

drug: SD-101

Not Recruiting

Contact Information

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

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