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Evaluate the Safety of agenT-797 in Participants With Moderate to Severe Difficulty Breathing Secondary to SARS-CoV-2

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04582201
Recruitment Status : Completed
First Posted : October 9, 2020
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
MiNK Therapeutics

Brief Summary:
A Phase 1/2 study of agenT-797 to treat moderate to severe acute respiratory distress syndrome (ARDS) secondary to acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or influenza.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Drug: agenT-797 Phase 1 Phase 2

Detailed Description:

This is a Phase 1/2 study to evaluate the safety and potential efficacy of agenT-797, an unmodified, allogeneic invariant natural killer T (iNKT) cell therapy, in participants with moderate to severe ARDS secondary to SARS-CoV-2 or influenza, either with intubation or at high risk to be intubated, as determined using Berlin definition(s).

Part 1 will employ a standard 3+3 dose escalation design of agenT-797. All participants will receive a single infusion of agenT-797. Participants will also receive other treatments and supportive care per discretion of the investigator. Once the maximum tolerated dose of agenT-797 has been cleared in Part 1, an Expansion Cohort will be opened.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of agenT-797 to Treat Moderate to Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2 or Influenza
Actual Study Start Date : September 21, 2020
Actual Primary Completion Date : June 2, 2022
Actual Study Completion Date : June 2, 2022


Arm Intervention/treatment
Experimental: Dosage and Cohorts

Cohort 1: 100 × 10^6 iNKT cells; Cohort 2: 300 × 10^6 iNKT cells; Cohorts 3 to 4: 1000 × 10^6 iNKT cells

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

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




Primary Outcome Measures :
  1. Number Of Participants With Treatment-emergent Adverse Events [ Time Frame: Baseline through Month 6 ]
  2. Number Of Participants With Dose-limiting Toxicities [ Time Frame: Baseline through Month 6 ]

Secondary Outcome Measures :
  1. Time To Extubation [ Time Frame: Up to Day 30 ]
  2. Mean Daily Sequential Organ Failure Assessment Score [ Time Frame: Day 30 ]
  3. Change From Baseline In C-reactive Protein [ Time Frame: Baseline through Day 30 (every 12 hours, as feasible) ]
    C-reactive protein levels will be used to assess cytokine release syndrome.

  4. Decay In Quantitative Viral Burden From Upper And Lower Respiratory Tract Samples [ Time Frame: Day 30 ]
  5. Time From Dosing To Viral Clearance [ Time Frame: Up to Day 30 ]
  6. Number Of Participants Experiencing Viral Reactivation And Fungal Infections [ Time Frame: Day 30 ]
    This outcome measure will determine if iNKT cells prevent reactivation of other viruses (cytomegalovirus, human papillomavirus, herpes simplex virus, Epstein-Barr virus) and fungal infections.



Information from the National Library of Medicine

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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 can provide informed consent or have a duly appointed health care proxy establish which/who has the authority to consent on behalf of the participant
  2. Inpatient hospitalization
  3. Evidence of SARS-CoV-2 infection with the diagnosis of moderate to severe ARDS secondary to SARS-CoV-2 or influenza per Berlin definition (ARDS 2012)
  4. Participants, or study participant's duly appointed health care proxy with the authority to consent on behalf of the participant, 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
  2. Clinically significant cardiomyopathy
  3. Pre-existing respiratory disease, such as significant chronic obstructive pulmonary disease requiring home oxygen, hospitalization, or systemic steroid use during the past year
  4. "Significant" pulmonary hypertension, defined as mean pulmonary artery pressure ≥ 20 millimeters of mercury and evidence of right ventricular dysfunction or enlargement
  5. Receipt of vaccines containing live virus within 4 weeks prior to first dose of study treatment
  6. Known hypersensitivity to donor-derived cell therapy or their preservation solution
  7. Active systemic bacterial or fungal infection or viral co-infection
  8. Pregnant or lactating women
  9. Presence of multiorgan dysfunction syndrome; no organ failure should be seen other than the organ of interest, which is the lung

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


Locations
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United States, California
Saint John's Cancer Institute
Santa Monica, California, United States, 90404
United States, Kentucky
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States, 40207
United States, New York
Weill Cornell Medicine New York Presbyterian
New York, New York, United States, 10022
Sponsors and Collaborators
MiNK Therapeutics
Investigators
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Study Director: Medical Director Agenus Inc.
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Responsible Party: MiNK Therapeutics
ClinicalTrials.gov Identifier: NCT04582201    
Other Study ID Numbers: C-1300-01
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: July 2022

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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 MiNK Therapeutics:
SARS-CoV-2
Influenza
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury