Phase i trial of a Toll-like receptor 9 agonist, PF-3512676 (CPG 7909), in patients with treatment-refractory, cutaneous T-cell lymphoma

Youn H. Kim, Michael Girardi, Madeleine Duvic, Timothy Kuzel, Brian K. Link, Lauren Pinter-Brown, Alain H. Rook

Research output: Contribution to journalArticlepeer-review

87 Scopus citations


Background: Mycosis fungoides and Sézary syndrome are a class of lymphomas of skin-trafficking T cells, and they are the most common forms of cutaneous T-cell lymphoma (CTCL). Mycosis fungoides and Sézary syndrome are chronic, frequently incurable diseases with limited therapeutic options. PF-3512676 (formerly CPG 7909) is a Toll-like receptor 9 agonist that is being investigated for treatment of patients with advanced cancer. Objective: This study was conducted to determine the safety and tolerability of single-agent PF-3512676 in patients with CTCL. Methods: In this phase I dose-escalation study, patients (N = 28) with treatment-refractory, stage IB to IVA CTCL were enrolled in 6 sequential cohorts and treated with PF-3512676 (0.08, 0.16, 0.24, 0.28, 0.32, or 0.36 mg/kg) administered as 24 weekly subcutaneous injections. Primary end points were safety and tolerability. Results: Common adverse events (fatigue, rigors, injection-site reactions, myalgia, lymphopenia, leukopenia, neutropenia, and pyrexia) were mostly grade 1 or 2, and no patient developed specific symptoms associated with autoimmune disease. Clinical response rate to PF-3512676, as determined by both Composite Assessment of Index Lesion Severity and Physician Global Assessment, was 32% (3 complete clinical responses, 6 partial responses); the majority of responses (7/9; 78%) were ongoing at the end of study. Limitations: This trial was not designed to rigorously assess efficacy. Conclusion: Single-agent PF-3512676 was well tolerated and demonstrated antitumor activity in patients with refractory CTCL.

Original languageEnglish (US)
Pages (from-to)975-983
Number of pages9
JournalJournal of the American Academy of Dermatology
Issue number6
StatePublished - Dec 2010


  • CPG oligodeoxynucleotides
  • Cancer immunotherapy
  • Cutaneous T-cell lymphoma
  • Immunotherapy
  • PF-3512676
  • Toll-like receptor 9

ASJC Scopus subject areas

  • Dermatology


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