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Clinical Trial 21134

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04596033

Phase: Phase I
Prinicipal Investigator: Creelan, Benjamin

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Study Title

A Phase 1 Study to Evaluate the Safety, Proliferation and Persistence of GEN-011, an Autologous Adoptive Cell Therapy Targeting Neoantigens in Solid Tumors


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.


Primary Objective: -to evaluate the safety and toxicities of GEN-011 given in 2 dosing regimens Secondary Objectives: -to determine the proliferation and persistence of GEN-011 cells in patients using antigen-specific T cell responses -to assess clinical response per RECIST and iRECIST criteria, including best response, duration of response (DoR), progression-free survival (PFS), and survival for those who do not progress up to 2 years post initial dose of GEN-011. Exploratory Objectives: -to assess immune cell phenotypes, T cell receptor (TCR) beta chain sequences, epitope spreading, and residual or new mutations in residual or recurrent tumor. -to assess immune cell infiltration of the tumor including quantitation, phenotype and proximity to tumor cells.



Chemotherapy (NOS); Immunotherapy


GEN-011 (); IL-2 (Interleukin-2); Lymphodepletion (); MESNA (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

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

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.