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Virus Therapy

SQZ-PBMC-HPV for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by SQZ Biotechnologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 6 weeks after the patient's last dose of investigational product
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that uses a patient's own immune cells to fight HPV16+ cancers. The treatment will be given alone or with other cancer treatments. The goal is to see if the treatment is safe and works against the cancer.

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best overall response (BoR) [Part 3]
Disease-control rate (DCR) [Part 3]
Duration of Response (DoR) [Part 3]
+5 more
Secondary outcome measures
Amount of investigational product (IP) from individual patient blood collection [Part 1]
Best overall response (BoR) [Part 1 and 2]
Disease-control rate (DCR) [Part 1 and 2]
+4 more
Other outcome measures
Number of patients with change in blood cytokine levels
Number of patients with development of endogenous immune responses as assessed by functional assay in CD8 T cells

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 3 Monotherapy Dose Expansion PhaseExperimental Treatment1 Intervention
In Part 3, SQZ-PBMC-HPV is administered at the RP2D to patients enrolled in HPV16+ cancer-type specific cohorts. There are 4 groups ("Cohorts") in this Phase as follows: Cohort 8: SQZ-PBMC-HPV RP2D in HPV16+ head and neck cancer patients Cohort 9: SQZ-PBMC-HPV RP2D in HPV16+ cervical cancer patients Cohort 10: SQZ-PBMC-HPV RP2D in HPV16+ anal cancer patients Cohort 11: SQZ-PBMC-HPV RP2D in other HPV16+ cancer patients
Group II: Part 2 Combination Safety PhaseExperimental Treatment4 Interventions
In Part 2, SQZ-PBMC-HPV in combination with immune checkpoint inhibitors (1) atezolizumab, (2) ipilimumab, (3) nivolumab, or (4) nivolumab and ipilimumab, is administered every 3 weeks for up to a year except atezolizumab may be given up to 2 years; and ipilimumab will be administered four times (in a timeframe less than a year) if safety allows. There are 4 groups ("Cohorts") in this Phase as follows: Cohort 4: SQZ-PBMC-HPV RP2D (Recommended Phase 2 Dose) plus atezolizumab Cohort 5: SQZ-PBMC-HPV RP2D plus ipilimumab Cohort 6: SQZ-PBMC-HPV RP2D plus nivolumab Cohort 7: SQZ-PBMC-HPV RP2D plus nivolumab and ipilimumab
Group III: Part 1 Monotherapy Dose Escalation PhaseExperimental Treatment1 Intervention
In Part 1, SQZ-PBMC-HPV as a monotherapy is administered on Day 1 of every 3 week cycles for up to a year. In Cohort 3 (double-priming), SQZ-PBMC-HPV is also administered on Day 2 of Cycle 1. There are at least 3 groups ("Cohorts") in this Phase as follows: Cohort 1: specified dose SQZ-PBMC-HPV Cohort 2: specified dose SQZ-PBMC-HPV Cohort 3: specified dose SQZ-PBMC-HPV double-priming
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
SQZ-PBMC-HPV
2020
Completed Phase 1
~30
Nivolumab
2014
Completed Phase 3
~4750
Atezolizumab
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

SQZ BiotechnologiesLead Sponsor
2 Previous Clinical Trials
25 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
2020. "Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04084951.
~6 spots leftby Apr 2025
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