A Phase 1 interventional study of GEN-011 and IL-2 in Melanoma, Non-small Cell Lung Cancer and Squamous Cell Carcinoma of Head and Neck, sponsored by Genocea Biosciences, Inc.. Terminated at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-15.
Sponsored by Genocea Biosciences, Inc. · Phase 1, Interventional, and Treatment
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.
TiTAN-1 is an open-label, multicenter, first-in-human Phase 1 study of GEN-011 in patients with melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC, bladder, ureter, urethra, or renal pelvis), renal cell carcinoma (RCC), small cell lung cancer (SCLC), cutaneous squamous cell carcinoma (CSCC), or anal squamous cell carcinoma (ASCC). Patients will be enrolled into one of 2 cohorts. One cohort will receive a multiple low dose (MLD) regimen of GEN-011 to be given without lymphodepletion, and a second cohort will receive a single high dose (SHD) regimen of GEN-011 after lymphodepletion. Regardless of cohort, each dose of GEN-011 will be followed by a course of interleukin-2 (IL-2) as costimulatory therapy.
GEN-011 is an investigational, personalized neoantigen adoptive cell therapy (ACT) that is being developed by Genocea for the treatment of adult patients with advanced solid tumors. A proprietary tool developed by Genocea called ATLAS™ (Antigen Lead Acquisition System) will be used to identify true immunogenic neoantigens from each patient's tumor that are recognized by their own CD4 and/or CD8 T cells. ATLAS-identified neoantigens will be used to stimulate and select autologous T cells collected by apheresis to generate an adoptive cell product ex vivo.
135 studies on the registry are indexed under Carcinoma, Merkel Cell; 37 are open to participants now.
This study's enrollment of 49 is above the median of 40 across 118 interventional studies indexed under Carcinoma, Merkel Cell.
Browse Carcinoma, Merkel Cell studies →Genocea Biosciences, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Biological: GEN-011 · Drug: IL-2
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.
Biological: GEN-011 · Drug: IL-2 · Drug: Fludarabine · Drug: Cyclophosphamide
Personalized neoantigen adoptive cell therapy (ACT)
Cytokine
Also known as: Interleukin-2
Lymphodepletion drug
Lymphodepletion drug
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
Time frame: 2 years after first GEN-011 infusion
T cell responses to GEN-011
Antigen-specific immunogenicity assays
Time frame: 2 years after first GEN-011 infusion
Duration of response
Measured by RECIST
Time frame: 2 years after first GEN-011 infusion
Progression-free survival
Length of time without disease progression
Time frame: 2 years after first GEN-011 infusion
Overall survival
Length of time patient remains alive
Time frame: From first GEN-011 infusion through study completion, at least 2 years
Immune cell phenotyping
Classification of peripheral immune cells via flow cytometry
Time frame: 2 years after first GEN-011 infusion
Epitope Spread
Tumor mutations will be identified by gene sequencing at multiple timepoints, and comparing the differences in mutations over time
Time frame: 4 weeks after first GEN-011 infusion
Tumor infiltrating immune cell
Quantitation and phenotyping of immune cells in proximity to tumor cells using immunohistochemistry
Time frame: 2 years after first GEN-011 infusion
This study is terminated, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Genocea Biosciences, Inc.