Clinical trial · Interventional
Study of Dynavax's 1018 ISS, Following Rituxan in Patients With B-Cell Follicular Lymphoma
A Phase 2, Open-Label Study of the Efficacy, Safety, and Tolerability of Dynavax's Immunostimulatory Phosphorothiolate Oligodeoxyribonucleotide, 1018 ISS, Following Rituxan (Rituximab) Treatment in Patients With CD20+, B-Cell Follicular Non-Hodgkin's Lymphoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to determine the effects (good and bad) and the safety of Dynavax's immunostimulatory phosphorothiolate oligodeoxyribonucleotide (1018 ISS) given in combination with Rituxan on patients with B-cell follicular non-Hodgkin's lymphoma. This research is being done because recurrent follicular non-Hodgkin's lymphoma is not curable with standard chemotherapy or antibody treatments. 1018 ISS is an experimental compound that consists of short pieces of DNA that stimulate the immune system. It is hoped that 1018 ISS may improve the ability of Rituxan to kill cancer cells.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1018 ISS | Drug | — | UNRESOLVED |
| Rituxan | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the proportion of patients who are alive and without disease progression 1 year after initiating Rituxan plus 1018 ISS therapy.
- timeFrame
- 2 years
Secondary outcomes (4)
- measure
- To assess the overall response rate following treatment
- timeFrame
- 2 years
- measure
- to determine duration of response and time to progression
- measure
- to further define the safety profile of 1018 ISS
- timeFrame
- 2 years
- measure
- to explore the biologic activity of 1018 ISS.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Pathological evidence of CD20+, B-cell follicular non-Hodgkin's lymphoma * Received at least one previous chemotherapy regimen for lymphoma * Hemoglobin \> 8.5 g/dl * WBC \> 2,000/mm3 * ANC \> 1,000/mm3 * Platelet count \> 75,000/mm3 * ECOG performance status of less than or equal to 2 * Life expectancy of greater than 4 months * Women and men of childbearing potential must be willing to use highly effective methods of birth control for duration of time on the study Exclusion Criteria: * Pregnant of lactating women * Treatment with chemotherapy, including systemic steroids, or radiation therapy within 30 days * Current use of systemic or inhaled steroids * Treatment with radioimmunotherapy, autologous stem cell transplantation, or fludarabine within 6 months * Disease progression within 6 months of any previous rituximab therapy * History of allogenic transplantation, including nonmyeloablative transplantation * Unstable angina, symptomatic cardiac arrhythmia or clinical heart failure * Severe pulmonary disease, symptomatic pleural effusions, or clinically significant pulmonary symptoms * Active infection requiring systemic antibiotic, antiviral, or antifungal therapy * Clinically apparent CNS lymphoma * Major surgery within 2 weeks * Known human anti-murine antibody (HAMA) or human anti-chimeric antibody (HACA) response * Known Hepatitis B surface antigen positive * History of autoimmune disorder * Current therapeutic use of anticoagulants * History of coagulopathy * Known allergy to any of the components of 1018 ISS or Rituxan * Participation in another investigational trial within 30 days * Any clinically significant abnormality in screening blood chemistry, hematology, or urinalysis
References
Publications (0)
Data not yet available