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An Experiment to Evaluate the Safety of agenT-797 in COVID-19 Patients With Severe Difficulty Breathing.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04582201
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Agenus Inc. ( AgenTus Therapeutics, Inc. )

Study Description
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Brief Summary:
A Phase 1 Study of AGENT-797 to treat moderate to severe acute respiratory syndrome in COVID-19 patients.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Drug: agenT-797 Phase 1

Detailed Description:

This is a Phase 1 study to evaluate the safety and efficacy of agenT-797, an unmodified, allogeneic iNKT therapy, in patients with coronavirus disease 2019 (COVID-19), requiring mechanical ventilation, and with moderate to severe ARDS as determined by the Berlin definition.

The study will be conducted in 2 parts. Part 1 will employ a standard 3+3 dose escalation design of agenT-797. All patients will receive a single infusion of agent-797. Patients will also receive other treatments and supportive care per discretion of the Principal Investigator. Once the maximum tolerated dose of agenT-797 has been cleared in Part 1, Part 2 of the study will be opened and enroll eligible patients in the Expansion Cohort.

Details of the analyses will be described in a statistical analysis plan.

A Safety Monitoring Committee will be established to assess safety and decide on escalation to next Cohort and expansion dose, as well as any protocol modification to include less severe cases.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of agenT-797 to Treat Moderate to Severe Acute Respiratory Syndrome in COVID-19 Patients
Actual Study Start Date : September 21, 2020
Estimated Primary Completion Date : April 24, 2021
Estimated Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dosage and Cohorts

Cohort 1 100 × 106 iNKT Cohort 2 300 × 106 iNKT Cohort 3 1000 × 106 iNKT

Dosage Frequency and Mode of Administration: agenT-797 will be administered to hospitalized patients as a single IV infusion.

 Drug: agenT-797
agenT-797 is an off-the shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex-vivo.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 months ]
    Number and severity of adverse events (AEs)

  2. Number of Dose Limiting Toxicities [ Time Frame: 6 months ]
    Number of Dose Limiting Toxicities


Secondary Outcome Measures :
  1. To assess time to improvement in pulmonary function. [ Time Frame: 30 days ]

    Time to extubation.

    Assessment of ventilator-free days.

    Oxygenation improvement as per Berlin definition (ARDS 2012).

    Supportive interventions used (e.g. use of prone ventilation, paralytics, pulmonary vasodilators, and other interventions affecting oxygenation).


  2. Amount of virus detected in respiratory tract samples. [ Time Frame: 30 days ]
    Decay in quantitative viral burden from upper and lower respiratory tract samples collected.

  3. To assess longevity of agenT-797 infusion. [ Time Frame: 30 days ]
    Persistence of allogeneic invariant natural killer T cells (iNKT) non-transduced cells.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Voluntarily agree to participate and ability to provide informed consent or have duly appointed health care proxy with the authority to consent.
  2. ≥ 18 years of age.
  3. Confirmed diagnosis of SARS-CoV-2 infection by polymerase chain reaction test or equivalent approved test.
  4. Inpatient hospitalization.
  5. Evidence of SARS-CoV-2 infection with the diagnosis of moderate to severe ARDS per Berlin definition (ARDS 2012), no more than 2 weeks prior to study enrollment.
  6. Patients, or duly appointed health care proxy with the authority to consent, must consent to placement of a central venous access line for the administration of agenT-797.

Exclusion Criteria:

  1. Currently participating and receiving study therapy of an investigational agent that is not registered for any other indication.

    Note: Patients may receive the standard of care for SARS-CoV-2 infection as per institutional practices.

  2. Presence of comorbidities limiting expected survival of < 1 month.
  3. Any comorbidity which in the opinion of the Investigator may preclude/confound study required safety and efficacy assessments.
  4. Clinically significant cardiomyopathy.
  5. Receipt of non-oncology vaccines containing live virus for prevention of infectious diseases within 4 weeks prior to first dose of study treatment.
  6. Known hypersensitivity to natural killer (NK) cells or their preservation solution.
  7. Active systemic bacterial or fungal infection or viral co-infection.
  8. Legally incapacitated or has limited legal capacity.
  9. Pregnant or lactating women.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582201


Contacts
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Contact: Agenus, Inc. Clinical Trial Information 781-674-4265 clinicaltrialinfo@agenusbio.com

Locations
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United States, New York
Weill Cornell Medicine New York Presbyterian Recruiting
New York, New York, United States, 10022
Contact: Koen Van Besien, MD, PhD         
Contact       kov9001@med.cornell.edu   
Principal Investigator: Koen Van Besien, MD         
Sponsors and Collaborators
AgenTus Therapeutics, Inc.
Investigators
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Study Director: Medical Director Agenus Inc.
More Information
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Responsible Party: AgenTus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04582201    
Other Study ID Numbers: C-1300-01
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Agenus Inc. ( AgenTus Therapeutics, Inc. ):
COVID-19
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury