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• W2256799441 abstract "6594 Background: CpG ODN are a class of chemically synthesized oligodeoxynucleotides that activate B-cells and plasmacytic dendritic cells through the pattern receptor Toll-like receptor 9. CpG ODN can increase CD20 expression on malignant B-cells in vitro and have been shown to enhance the efficacy of antibody therapy in murine models. An early clinical trial showed responses to CpG 7909 (ProMune) in two NHL patients treated with single agent IV CpG 7909. We report a phase I trial of escalating doses of CpG, administered IV or SC, in combination with standard dose rituximab (Rituxan [R]) to assess safety of the combination. Methods: Patients with relapsed or refractory NHL who were candidates for [R] as a single agent were enrolled in one of three cohorts. All received [R] weekly times 4, with each dose of [R] followed by a dose of CpG. Cohort 1 (19 subjects) received 4 weekly doses of CpG SC (0.01, 0.04, 0.08, or 0.16 mg/kg). Cohort 2 (19 subjects) received 4 weekly doses of CpG IV (0.04, 0.16, 0.32, or 0.48 mg/kg). Cohort 3 (12 subjects) received 0.24 mg/kg SC weekly for 20 weeks. Subjects were monitored for toxicity and tumor response. Histologically, 24 of 50 subjects had follicular lymphoma. Thirty-three patients had received prior [R], and a number were refractory to their most recent [R]. Results: The combination of CpG + [R] was well tolerated with transient Grade 1 and 2 local injection site reactions, arthalgias, and myalgias. Significant adverse events included lymphopenia (2= Gr3), neutropenia (1=Gr3, 1=Gr4), diarrhea (1=Gr3), and dehydration (1= Gr3). There were 7 objective responses within 50 days of the initiation of therapy (Cohort 1 - 1CR and 1PR; Cohort 2 - 2 CR and 3 PR;) and 5 responses (Cohort 3 - 1 CR and 4 PR) within 20 weeks. Cytokine and chemokine measurements demonstrated biological activity in the SQ cohorts. Conclusions: CpG can be given safely in combination with [R] in NHL patients by both the IV and SQ route, without apparent exacerbation of [R] related infusion toxicity. Further follow-up is needed to determine the response rate and duration of response to this combination immunotherapy. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Coley Pharmaceutical Group Coley Pharmaceutical Group Coley Pharmaceutical Group Coley Pharmaceutical Group Coley Pharmacutical Group" @default.
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• W2256799441 date "2004-07-15" @default.
• W2256799441 modified "2023-10-07" @default.
• W2256799441 title "Combination of CpG7909 and rituximab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL): A phase I, open label dose-escalation study of safety and tolerability" @default.
• W2256799441 doi "https://doi.org/10.1200/jco.2004.22.14_suppl.6594" @default.
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