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

A Phase 1/2 Study of agenT-797 to Treat Moderate to Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2 or Influenza

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Adult
• Intervention / Treatment: Drug: agenT-797

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Saint John's Cancer Institute
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute, St. Matthews Campus
  • New York
    • New York, New York, United States, 10022
      • Weill Cornell Medicine New York Presbyterian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number Of Participants With Treatment-emergent Adverse Events	Baseline through Month 6
Number Of Participants With Dose-limiting Toxicities	Baseline through Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time To Extubation		Up to Day 30
Mean Daily Sequential Organ Failure Assessment Score		Day 30
Change From Baseline In C-reactive Protein	C-reactive protein levels will be used to assess cytokine release syndrome.	Baseline through Day 30 (every 12 hours, as feasible)
Decay In Quantitative Viral Burden From Upper And Lower Respiratory Tract Samples		Day 30
Time From Dosing To Viral Clearance		Up to Day 30
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.	Day 30

Collaborators and Investigators

• Sponsor: MiNK Therapeutics
• Investigators: Study Director: Medical Director, MiNK Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): April 23, 2023
• Study Completion (Actual): April 23, 2023

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Influenza
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: C-1300-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No