Study Stopped
Business reasons
TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy
A Phase 1 Study to Evaluate the Safety, Proliferation and Persistence of GEN-011, an Autologous Adoptive Cell Therapy Targeting Neoantigens in Solid Tumors
1 other identifier
interventional
49
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2020
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
November 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2022
CompletedJuly 15, 2022
July 1, 2022
1.6 years
September 30, 2020
July 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Adverse events will be graded according to the NC Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
2 years after first GEN-011 infusion
Secondary Outcomes (4)
T cell responses to GEN-011
2 years after first GEN-011 infusion
Duration of response
2 years after first GEN-011 infusion
Progression-free survival
2 years after first GEN-011 infusion
Overall survival
From first GEN-011 infusion through study completion, at least 2 years
Other Outcomes (3)
Immune cell phenotyping
2 years after first GEN-011 infusion
Epitope Spread
4 weeks after first GEN-011 infusion
Tumor infiltrating immune cell
2 years after first GEN-011 infusion
Study Arms (2)
Multiple Low Dose (MLD)
EXPERIMENTALGEN-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.
Single High Dose (SHD)
EXPERIMENTALGEN-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.
Interventions
Personalized neoantigen adoptive cell therapy (ACT)
Eligibility Criteria
You may qualify if:
- Consents to study procedures
- Diagnosis of one of the following solid tumors: cutaneous melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), renal cell carcinoma (RCC), small cell lung cancer (SCLC), cutaneous squamous cell carcinoma (CSCC), anal squamous cell carcinoma (ASCC), merkel cell carcinoma (MCC).
- Received, been intolerant of, or been ineligible to receive standard of care treatment regimen.
- Measurable disease per RECIST criteria
- Life expectancy \> 6 months and ECOG status 0 or 1
- Capacity to tolerate lymphodepletion (SHD group only) and IL-2 therapy
- Tumor tissue available
- Willing to use contraceptives for 90 days after receiving GEN-011, and not currently pregnant.
- Adequate blood, liver, kidney, and lung function
- Sufficient stimulatory neoantigens identified in ATLAS
You may not qualify if:
- Receiving immunosuppressive medications
- Serious ongoing viral, bacterial, or fungal infection
- History of cardiac arrhythmias or significant heart block
- History of leptomeningeal carcinomatosis
- Active autoimmune disease
- Portal vein thrombosis
- Malignant disease other than those treated in this study
- Receiving other investigational anti-cancer therapy
- Prior stem cell or solid organ transplant
- Primary immune deficiency disease
- Significant ongoing toxicities from prior therapies
- A history of allergic reaction to sulfur derivatives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Columbia University Medical Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thomas Davis, MD
Genocea Biosciences, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2020
First Posted
October 22, 2020
Study Start
November 11, 2020
Primary Completion
June 27, 2022
Study Completion
June 27, 2022
Last Updated
July 15, 2022
Record last verified: 2022-07