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CAR T-cell Therapy

GEN-011 for Squamous Cell Carcinoma

Phase 1
Waitlist Available
Research Sponsored by Genocea Biosciences, Inc.
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 4 weeks after first gen-011 infusion
Awards & highlights

Summary

TiTAN-1 is a first-in-human study of GEN-011, an experimental treatment being evaluated in adult patients with advanced cancer. GEN-011 is a T cell therapy made specific to each patient, using the patient's own circulating immune cells. First, Genocea confirms which cancer proteins are recognized already by each patient's T cells using ATLAS™. Then, immune cells that recognize these cancer proteins are multiplied many times (a process called PLANET™) to create a personalized GEN-011 cell therapy, which is given back to the patient in one or more intravenous (IV) infusions.

Eligible Conditions
  • Squamous Cell Carcinoma
  • Anal Carcinoma
  • Non-Small Cell Lung Cancer
  • Melanoma
  • Neuroendocrine Carcinoma
  • Bladder Cancer
  • Kidney Cancer
  • Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after first gen-011 infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after first gen-011 infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
Duration of response
Overall survival
Progression-free survival
+1 more
Other outcome measures
Epitope Spread
Immune cell phenotyping
Tumor infiltrating immune cell

Trial Design

2Treatment groups
Experimental Treatment
Group I: Single High Dose (SHD)Experimental Treatment4 Interventions
GEN-011 is administered as a single IV infusion at the maximum available cell yield, after the patient completes a fludarabine/cyclophosphamide lymphodepletion regimen. The single GEN-011 dose is followed by IL-2 administration.
Group II: Multiple Low Dose (MLD)Experimental Treatment2 Interventions
GEN-011 is administered by IV infusion at 4-week intervals, up to 5 doses maximum. Each dose is followed by IL-2 administration. MLD patients will not undergo lymphodepletion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IL-2
2007
Completed Phase 4
~1180
Fludarabine
2012
Completed Phase 4
~1860
Cyclophosphamide
2010
Completed Phase 4
~2320

Find a Location

Who is running the clinical trial?

Genocea Biosciences, Inc.Lead Sponsor
9 Previous Clinical Trials
1,006 Total Patients Enrolled
Thomas Davis, MDStudy DirectorGenocea Biosciences, Inc.
2 Previous Clinical Trials
13,000 Total Patients Enrolled
~10 spots leftby Sep 2025
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