Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3) as immunotherapy for patients with recurrent/metastatic lung cancer
- Conditions
- lung cancer
- Registration Number
- JPRN-UMIN000023276
- Lead Sponsor
- Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine
- Brief Summary
o DLTs at any dose level. No serious treatment-related adverse events. Serum IFN-a2 levels increased in six patients after the third administration of CpG ODN (K3). Serum IFN-g and CXCL10 levels increased in eight patients after the third administration. The percentage of T-bet-expressing CD8+ T cells increased. Both T-bet-expressing effector memory (p = 0.0195) and terminally differentiated effector memory (p = 0.0039) CD8+ T cells significantly increased. The median PFS was 398 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 9
Not provided
1) Synchronous or metachronous malignancies 2) Symptomatic brain metastasis 3) Massive pleural effusion required for tube drainage 4) Infectious disease requiring systemic treatment 5) Positive test for hepatitis B virus antigen or hepatitis C virus or human immunodeficiency virus 6) History of unstable angina or myocardial infarction 7) Interstitial pneumonia on chest CT 8) History of antiphospholipid antibody syndrome 9) Subjects with active, known or suspected autoimmune disease 10) Current use of aspirin, or anticlotting drug or thrombolytic agent 11) Receiving continuous systemic corticosteroid treatment 12) Pregnant status or lactation 13) Severe psychological disorder 14) Other ineligible status judged by medical oncologist
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of safety
- Secondary Outcome Measures
Name Time Method Progression-free survival Assessment of specific immune response Adverse event