Status:
COMPLETED
Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
SQZ Biotechnologies
Conditions:
Adult Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ate...
Eligibility Criteria
Inclusion
- Key
- 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 leukapheresis 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 prior to the leukapheresis
Exclusion
- 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
Key Trial Info
Start Date :
January 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04084951
Start Date
January 28 2020
End Date
February 9 2023
Last Update
April 14 2023
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
HonorHealth
Scottsdale, Arizona, United States, 85258
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
University of Colorado Anschutz Cancer Pavillion
Aurora, Colorado, United States, 80045
4
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160