Intratumoral Injection of an Immunostimulatory CpG, SD-101, Combined With Local Radiation for the Treatment of Recurrent or Progressive Lymphoma After Allogeneic Hematopoietic Cell Transplantation

Inclusion Criteria:

1. Biopsy-confirmed relapsed, refractory, or progressive NHL or HL (Refer to Section
3.2.1 for excluded subtypes)

2. At least 3 sites of disease

i. One for diagnosis (lymph node or bone marrow biopsy)

ii. One palpable for treatment

iii. One measurable radiographically

3. > 60 days after RIC allogeneic transplant for lymphoma

4. 18 years of age or older

5. Mixed (5-95%) or complete (>95%) chimerism

6. Eastern Oncology Cooperative Group (ECOG) performance status ≤ 2

7. ANC >1000/mm3, platelets >50,000/mm3

8. Total bilirubin ≤ 2.5 mg/dL, AST and ALT < 3 times upper limit of normal

9. Serum creatinine ≤ 3 mg/dL

10. No chemotherapy, RT, DLI or biologic therapy for lymphoma at least 4 weeks prior to
scheduled treatment

11. Minimal immunosuppression (defined as monotherapy with ≤ 10 mg prednisone daily, ≤
200 mg cyclosporine daily, or ≤ 2 mg tacrolimus daily) at least 2 weeks prior to
scheduled treatment

Exclusion Criteria

1. HIV associated lymphoma

2. Acute GVHD at time of enrollment (history of treated and resolved GVHD is permitted)

3. Active infection within 14 days prior to scheduled treatment

4. Active Cytomegalovirus (CMV) disease at the time of enrollment

5. Pre-existing autoimmune or antibody mediated disease (including systemic lupus
erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, and
autoimmune thrombocytopenia)

6. Pregnant