VTX-2337 in Combination With Radiotherapy in Patients Low-Grade B-cell Lymphomas

A Phase I/II Study of Intratumoral Injection of the Small Molecule TLR8 Agonist VTX-2337 in Combination With Local Radiation in Low-Grade B-cell Lymphomas

This study is to determine the safety and effectiveness of VTX-2337 (an investigational drug that stimulates the immune system) in combination with radiation therapy in treating patients with low-grade B-cell lymphoma. Patients will receive 2 low doses of radiotherapy, and 9 intratumoral injections of VTX-2337 over the course of 3 months.

Major Inclusion Criteria:

• low grade B cell lymphoma
• 1 or more sites of disease appropriate for intratumoral injection
• measurable disease other than the injection site
• Performance Status of 1 or better
• Adequate bone marrow, renal and hepatic function
• No active autoimmune disease or systemic immunosuppressive drugs
• Life expectancy > 4 months

Exclusion Criteria:

• Known HIV
• Known brain metastases
• Malignancy within last 5 yrs (basal cell or non-invasive squamous cell carcinoma OK)
• Anticoagulation therapy other than 325mg QD ASA
• Significant cardiovascular disease
• Pregnant or nursing