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
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Celgene
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
VTX-2337 plus radiation
Intervention: VTX-2337 plus radiotherapy (Drug)
Outcomes
Primary Outcomes
Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation.
Time Frame: Tumor assessment conducted at 12 weeks and every 3-6 months thereafter
Tumor response was assessed via CT scans of the chest, abdomen, pelvis or other medically appropriate imaging modality to evaluate all areas of disease. Cheson Criteria were used for calculation of response.
Secondary Outcomes
- Assess the Safety and Feasibility of the Combination Regimen.(Safety assessed throughout study period.)