TiTAN-1: Safety Proliferation and Persistence of GEN-011 Autologous Cell Therapy

  • End date
    May 26, 2024
  • participants needed
  • sponsor
    Genocea Biosciences, Inc.
Updated on 26 November 2021
measurable disease
melanoma skin
squamous cell carcinoma
lung cancer
interleukin 2
lung carcinoma
malignant melanoma of skin
urothelial carcinoma


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.

Condition Non-Small Cell Lung Cancer, Adenocarcinoma, Malignant neoplasm of kidney, Neuroendocrine carcinoma, melanoma, Squamous cell carcinoma, Transitional cell carcinoma, Renal Cell Carcinoma, skin cancer, Small Cell Lung Cancer, Merkel cell carcinoma, head and neck cancer, Metastatic Melanoma, Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma of Head and Neck, Anal Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Skin Squamous Cell Carcinoma, Kidney Cancer, Malignant Melanoma, Malignant Adenoma, Renal Cell Cancer, Renal Cancer, Urothelial Carcinoma, clear cell renal cell carcinoma, nsclc, sclc, small cell carcinoma, small cell carcinoma of the lung, squamous cell skin cancer
Treatment cyclophosphamide, Fludarabine, IL-2, GEN-011
Clinical Study IdentifierNCT04596033
SponsorGenocea Biosciences, Inc.
Last Modified on26 November 2021


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Receiving immunosuppressive medications
Serious ongoing viral, bacterial, or fungal infection
History of cardiac arrythmias 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
Clear my responses

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