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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04596033.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: David Henry Aggen
Phone: 646-422-4679
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterStatus: Active
Name Not Available
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.
Lead OrganizationGenocea Biosciences, Inc.
