Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
Completed · Phase 1
Conditions studied: Adult Solid Tumor
In brief
This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-PBMC-HPV as monotherapy and in combination with atezolizumab or other 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.
Key facts
- Study ID
- NCT04084951
- Run by
- SQZ Biotechnologies
- People needed
- 30
- Starts
- 2020-01-28
- Expected to finish
- 2023-02-09
- Last updated by the study team
- 2023-04-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- HonorHealth — Scottsdale, Arizona, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- University of Colorado Anschutz Cancer Pavillion — Aurora, Colorado, United States
- University of Kansas Cancer Center — Kansas City, Kansas, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- The Masonic Cancer Center University of Minnesota — Minneapolis, Minnesota, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
- Providence Cancer Institute — Portland, Oregon, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada
- University Hospital Cologne, Clinic I for Internal Medicine — Cologne, Germany
Full record on ClinicalTrials.gov
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