Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy

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Transitional cell carcinoma
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Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy The Cxbladder Monitoring Study Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma A Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina A Clinical Study of PD-L1 Antibody ZKAB001（Drug Code） in Locally Advanced and Metastatic Urothelial Carcinoma Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma Radium-223 and Atezolizumab in Patients With Urothelial Carcinoma With Bone Metastases Who Have Had Disease Progression After Platinum-Based Chemotherapy An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium Application of UCAD for Diagnosing Urothelial Carcinoma. 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Brief Title

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

Official 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

Brief Summary

      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.

Detailed Description

      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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Incidence of Treatment-Emergent Adverse Events

Secondary Outcome

 T cell responses to GEN-011

Condition

Melanoma

Intervention

GEN-011

Study Arms / Comparison Groups

 Multiple Low Dose (MLD)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

49

Start Date

November 11, 2020

Completion Date

June 27, 2022

Primary Completion Date

June 27, 2022

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), 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 arrhythmias 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Thomas Davis, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT04596033

Organization ID

GEN-011-101

Responsible Party

Sponsor

Study Sponsor

Genocea Biosciences, Inc.

Study Sponsor

Thomas Davis, MD, Study Director, Genocea Biosciences, Inc.

Verification Date

July 2022