Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04084951 |
Recruitment Status :
Recruiting
First Posted : September 10, 2019
Last Update Posted : December 10, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adult Solid Tumor | Biological: SQZ-PBMC-HPV Drug: Atezolizumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Semi-sequential enrollment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of SQZ-PBMC-HPV as Monotherapy and in Combination With Atezolizumab in HLA-A*02+ Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors |
Estimated Study Start Date : | December 2019 |
Estimated Primary Completion Date : | November 2022 |
Estimated Study Completion Date : | November 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Dose escalation of SQZ-PBMC-HPV
In the monotherapy escalation cohorts, SQZ-PBMC-HPV is given for up to 3 administrations at intervals of 3 weeks as a low and a high cell dose. In addition, a second low cell dose cohort will test the impact of additional vaccination boosts of SQZ-PBMC-HPV.
|
Biological: SQZ-PBMC-HPV
antigen presenting cell therapy; therapeutic vaccine consisting of autologous peripheral blood mononuclear cells (PBMCs) presenting immunogenic epitopes of the E6 and E7 proteins of HPV16 |
Experimental: Dose escalation of SQZ-PBMC-HPV + atezolizumab
In the combination escalation cohorts, SQZ-PBMC-HPV in combination with atezolizumab is given for up to 3 administrations at intervals of 3 weeks as a low and a high cell dose. In addition, a second low cell dose cohort will test the impact of additional vaccination boosts of SQZ-PBMC-HPV given in combination with atezolizumab. Participants may continue to receive atezolizumab study drug every 3 weeks for a maximum of 1 year or until discontinuation criteria are met.
|
Biological: SQZ-PBMC-HPV
antigen presenting cell therapy; therapeutic vaccine consisting of autologous peripheral blood mononuclear cells (PBMCs) presenting immunogenic epitopes of the E6 and E7 proteins of HPV16 Drug: Atezolizumab programmed cell death ligand 1 (PD-L1) blocking antibody |
- Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0 [ Time Frame: approximately 10 months ]For SQZ-PBMC-HPV as a single agent and in combination with atezolizumab
- Maximum tolerated dose (MTD) [ Time Frame: approximately 6 weeks ]MTD of SQZ-PBMC-HPV as a single agent and in combination with atezolizumab
- Recommended Phase 2 dose (RP2D) [ Time Frame: approximately 10 months ]RP2D of SQZ-PBMC-HPV as a single agent and in combination with atezolizumab
- Number of patients with development of endogenous immune responses via ELISPOT in CD8 T cells [ Time Frame: Up to 1 year ]Immunogenic effects on peripheral blood cells of SQZ-PBMC-HPV as a single agent and in combination with atezolizumab
- Antitumor activity [ Time Frame: Up to 1 year ]Tumor assessments using RECIST 1.1 of SQZ PBMC-HPV monotherapy and in combination with atezolizumab
- Number of patients with change in blood cytokine levels [ Time Frame: Up to 1 year ]SQZ-PBMC-HPV as a single agent and in combination with atezolizumab

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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
- Known active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
- History of any Grade 4 immune-related AE (irAE) from prior immunotherapy
- Significant acute or chronic illness
- Major surgery within 2 weeks of leukapheresis

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084951
Contact: Nicole D'Auteuil | 978-758-9060 | nicole.dauteuil@sqzbiotech.com |
United States, Arizona | |
HonorHealth | Recruiting |
Scottsdale, Arizona, United States, 85258 | |
Contact: Joyce Schaffer 480-323-1364 clinicaltrials@honorhealth.com | |
Principal Investigator: Michael S Gordon, MD | |
United States, Colorado | |
University of Colorado Anschutz Cancer Pavillion | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Ana Nguyen 720-848-4394 ana.nguyen@cuanschutz.edu | |
Principal Investigator: Antonio Jimeno, MD, PhD | |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37212 | |
Contact: Clinical Trials Information Program 800-811-8480 CIP@vumc.org | |
Principal Investigator: Cathy Eng, MD | |
United States, Texas | |
MD Anderson Cancer Center | Not yet recruiting |
Houston, Texas, United States, 77030 | |
Contact: Abha Adat 713-745-4297 aadat@mdanderson.org | |
Principal Investigator: Filip Janku, MD |
Responsible Party: | SQZ Biotechnologies |
ClinicalTrials.gov Identifier: | NCT04084951 History of Changes |
Other Study ID Numbers: |
SQZ-PBMC-HPV-101 |
First Posted: | September 10, 2019 Key Record Dates |
Last Update Posted: | December 10, 2019 |
Last Verified: | November 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Solid tumors cancer metastatic locally advanced cancer cervical head and neck anal |
penile SQZ-PBMC-HPV atezolizumab HPV16 APC cell therapy |
Neoplasms Atezolizumab Antibodies, Monoclonal |
Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs |