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BRIEF TITLE: Proliferation and Persistence of GEN-011, an Autologous Adoptive Cell Therapy Targeting Neoantigens in Solid Tumors

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


  • Org Study ID: GEN-011-101
  • Secondary ID:
  • NCT ID: NCT04596033
  • NCT Alias:
  • Sponsor: Genocea Biosciences, Inc. - Industry
  • Source: Genocea Biosciences, Inc.

Brief Summary

GEN-011 is 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 finds which cancer proteins are recognized already by the patient's T cells using ATLAS™. Then, immune cells that recognize these cancer proteins are multiplied many times to create the GEN-011 cell therapy. The personalized GEN-011 is then given back to the patient in one or more intravenous (IV) infusions.

Detailed Description


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.

This 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.

Overal Status Start Date Phase Study Type
Recruiting October 2020 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Incidence of Treatment-Emergent Adverse Events

Primary Outcome 1 - Time Frame: 2 years after first GEN-011 infusion

Condition:

  • Melanoma
  • Non-small Cell Lung Cancer
  • Squamous Cell Carcinoma of Head and Neck
  • Urothelial Carcinoma
  • Renal Cell Carcinoma
  • Small-cell Lung Cancer
  • Cutaneous Squamous Cell Carcinoma
  • Anal Squamous Cell Carcinoma

Eligibility

Criteria:
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)

- 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Thomas Davis, MD

Role: Study Director

Affiliation: Genocea Biosciences, Inc.

Overall Contact

Name: Richard Hernandez

Phone: 617-876-8191

Email: richard.hernandez@genocea.com

Location

Facility Status Contact
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Recruiting Ask Sarah
615-339-4214
asksarah@sarahcannon.com