Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SQZ Biotechnologies
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patients ≥18 years of age who are HLA-A\*02+ (performed during screening locally or centrally, or based on documented historic test results)
Histologically confirmed incurable or metastatic solid tumors that are HPV16+ (performed during screening locally or centrally, or based on documented historic test results)
Cancer must have progressed after at least 1 available standard therapy for incurable disease, or the patient is intolerant to or refuses standard therapy(ies) or has a tumor for which no standard therapy(ies) exist
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1
At least 1 measurable lesion according to RECIST 1.1
Must have a lesion that can be biopsied with acceptable clinical risk and agree to have a fresh biopsy at Baseline and on Cycle 2 Day 8 (+/- 3 days)
Patients must agree to venous access for the blood collection for manufacture of autologous blood product and be willing to have a central line inserted if venous access is an issue
Adequate organ function and bone marrow reserve performed within 14 days of blood collection for manufacture of autologous blood product
You may not be if
Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to blood collection for manufacture of autologous blood product. For prior therapies with a half-life longer than 3 days, discontinuation of the therapy must have occurred at least 28 days prior to Cycle 1 Day 1
Systemic treatment with either corticosteroids (\>10 mg of prednisone or the equivalent per day) or other immunosuppressive medications within 14 days prior to Cycle 1 Day 1
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 blood collection for manufacture of autologous blood product, except Grade 2 alopecia
Known active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
History of any Grade 4 immune-related AE (irAE) from prior immunotherapy
Has known active central nervous system metastases
History of interstitial lung disease requiring steroids
Significant acute or chronic illness
Major surgery within 2 weeks of blood collection for manufacture of autologous blood product
Clareo Health | Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
