Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

Exclusion Criteria

• •Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to leukapheresis. For prior therapies with a half-life longer than 3 days, discontinuation of the therapy must have occurred at least 28 days prior to leukapheresis
• •Systemic treatment with either corticosteroids (\>10 mg of prednisone or the equivalent per day) or other immunosuppressive medications within 14 days prior to leukapheresis
• •Patients treated with non-corticosteroid based immunosuppressive agents within the last 6 months may not be eligible and should be discussed with the Sponsor
• •Patients with active, known, or suspected autoimmune disease may not be eligible and should be discussed with the Sponsor
• •Patients with \>Grade 1 AEs related to previous treatment with anticancer or investigational therapy that do not resolve at least 2 weeks prior to leukapheresis, except neuropathy, ototoxicity, mucositis, fatigue, alopecia, or endocrine disorders managed with hormone replacement
• •Known active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
• •History of any Grade 3 immune-related AE (irAE) from prior immunotherapy
• •Has known active central nervous system metastases
• •History of interstitial lung disease requiring steroids
• •Major surgery within 2 weeks of leukapheresis