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

Primary Purpose

Respiratory Distress Syndrome, Adult

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

agenT-797

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Adult focused on measuring SARS-CoV-2, Influenza

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Inpatient hospitalization
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)
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:

Currently participating and receiving study therapy of an investigational agent that is not registered for any other indication
Clinically significant cardiomyopathy
Pre-existing respiratory disease, such as significant chronic obstructive pulmonary disease requiring home oxygen, hospitalization, or systemic steroid use during the past year
"Significant" pulmonary hypertension, defined as mean pulmonary artery pressure ≥ 20 millimeters of mercury and evidence of right ventricular dysfunction or enlargement
Receipt of vaccines containing live virus within 4 weeks prior to first dose of study treatment
Known hypersensitivity to donor-derived cell therapy or their preservation solution
Active systemic bacterial or fungal infection or viral co-infection
Pregnant or lactating women
Presence of multiorgan dysfunction syndrome; no organ failure should be seen other than the organ of interest, which is the lung

Sites / Locations

Saint John's Cancer Institute
Norton Cancer Institute, St. Matthews Campus
Weill Cornell Medicine New York Presbyterian

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dosage and Cohorts

Arm Description

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.

Outcomes

Primary Outcome Measures

Number Of Participants With Treatment-emergent Adverse Events

Number Of Participants With Dose-limiting Toxicities

Secondary Outcome Measures

Time To Extubation

Mean Daily Sequential Organ Failure Assessment Score

Change From Baseline In C-reactive Protein

C-reactive protein levels will be used to assess cytokine release syndrome.

Decay In Quantitative Viral Burden From Upper And Lower Respiratory Tract Samples

Time From Dosing To Viral Clearance

Number Of Participants Experiencing Viral Reactivation And Fungal Infections

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.

Full Information

NCT ID

NCT04582201

First Posted

October 6, 2020

Last Updated

June 30, 2023

Sponsor

MiNK Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT04582201

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 21, 2020 (Actual)

Primary Completion Date

August 31, 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MiNK Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Distress Syndrome, Adult

Keywords

SARS-CoV-2, Influenza

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dosage and Cohorts

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

agenT-797

Intervention Description

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 Measure Information:

Title

Number Of Participants With Treatment-emergent Adverse Events

Time Frame

Baseline through Month 6

Title

Number Of Participants With Dose-limiting Toxicities

Time Frame

Baseline through Month 6

Secondary Outcome Measure Information:

Title

Time To Extubation

Time Frame

Up to Day 30

Title

Mean Daily Sequential Organ Failure Assessment Score

Time Frame

Day 30

Title

Change From Baseline In C-reactive Protein

Description

C-reactive protein levels will be used to assess cytokine release syndrome.

Time Frame

Baseline through Day 30 (every 12 hours, as feasible)

Title

Decay In Quantitative Viral Burden From Upper And Lower Respiratory Tract Samples

Time Frame

Day 30

Title

Time From Dosing To Viral Clearance

Time Frame

Up to Day 30

Title

Number Of Participants Experiencing Viral Reactivation And Fungal Infections

Description

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.

Time Frame

Day 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Inpatient hospitalization 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) 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: Currently participating and receiving study therapy of an investigational agent that is not registered for any other indication Clinically significant cardiomyopathy Pre-existing respiratory disease, such as significant chronic obstructive pulmonary disease requiring home oxygen, hospitalization, or systemic steroid use during the past year "Significant" pulmonary hypertension, defined as mean pulmonary artery pressure ≥ 20 millimeters of mercury and evidence of right ventricular dysfunction or enlargement Receipt of vaccines containing live virus within 4 weeks prior to first dose of study treatment Known hypersensitivity to donor-derived cell therapy or their preservation solution Active systemic bacterial or fungal infection or viral co-infection Pregnant or lactating women Presence of multiorgan dysfunction syndrome; no organ failure should be seen other than the organ of interest, which is the lung

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Agenus Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Saint John's Cancer Institute

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Norton Cancer Institute, St. Matthews Campus

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Weill Cornell Medicine New York Presbyterian

City

New York

State/Province

New York

ZIP/Postal Code

10022

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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