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

Respiratory Distress Syndrome, Adult Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582201
• Other study ID #: C-1300-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 21, 2020
• Est. completion date: April 23, 2023

Study information

• Verified date: April 2024
• Source: MiNK Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 23, 2023
• Est. primary completion date: April 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Norton Cancer Institute, St. Matthews Campus	Louisville	Kentucky
United States	Weill Cornell Medicine New York Presbyterian	New York	New York
United States	Saint John's Cancer Institute	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
MiNK Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number Of Participants With Treatment-emergent Adverse Events		Baseline through Month 6
Primary	Number Of Participants With Dose-limiting Toxicities		Baseline through Month 6
Secondary	Time To Extubation		Up to Day 30
Secondary	Mean Daily Sequential Organ Failure Assessment Score		Day 30
Secondary	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)
Secondary	Decay In Quantitative Viral Burden From Upper And Lower Respiratory Tract Samples		Day 30
Secondary	Time From Dosing To Viral Clearance		Up to Day 30
Secondary	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