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

• ClinicalTrials.gov Identifier: NCT04582201
• Recruitment Status: Completed
• First Posted: October 9, 2020
• Last Update Posted: April 9, 2024
• Sponsor: MiNK Therapeutics
• Information provided by (Responsible Party): MiNK Therapeutics

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.

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.

Study Design

• 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: April 23, 2023
• Actual Study Completion Date: April 23, 2023

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Director: Medical Director; MiNK Therapeutics

More Information

• Responsible Party: MiNK Therapeutics
• ClinicalTrials.gov Identifier: NCT04582201
• Other Study ID Numbers: C-1300-01
• First Posted: October 9, 2020
• Last Update Posted: April 9, 2024
• Last Verified: April 2024

• 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:

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