for people ages 18 years and up (full criteria)
study started
estimated completion
Principal Investigator
by Sandip Patel, MD (ucsd)
Headshot of Sandip Patel
Sandip Patel



This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-AAC-HPV as monotherapy and in combination with immune checkpoint inhibitors in HLA-A*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumors. The study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.

Official Title

A Phase 1, Multicenter, Open-Label Study of SQZ-AAC-HPV as Monotherapy and in Combination With Immune Checkpoint Inhibitors in HLA-A*02+ Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors


Adult Solid Tumor solid tumors cancer metastatic locally advanced cancer cervical head and neck anal penile SQZ-AAC-HPV HPV16 AAC cell therapy ipilimumab nivolumab checkpoint inhibitors immunotherapy solid tumor HLA-A*02 therapeutic vaccine recurrent cancer advanced solid tumor Neoplasms


You can join if…

Open to people ages 18 years and up

  • Male or female patients ≥18 years of age who are HLA-A*02+
  • Histologically confirmed incurable or metastatic solid tumors that are HPV16+
  • 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 CAN'T join 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


  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • City of Hope Medical Center accepting new patients
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Sandip Patel, MD (ucsd)
    Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 44 research publications. Research interests: cancer immunotherapy · phase 1 clinical trials · cellular therapy · immunometabolism · microbiome · IDO · personalized medicine · precision medicine · CAR-T cell · NK cell · proteomics · immunotherapy


accepting new patients
Start Date
Completion Date
SQZ Biotechnologies
Phase 1 research study
Study Type
Expecting 72 study participants
Last Updated