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

Phase 1

Completed

• Conditions: Respiratory Distress Syndrome, Adult
• Interventions: Drug: agenT-797

• Registration Number: NCT04582201
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-09-21
• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-09
• Primary Completion: 2023-04-23
• Study Completion: 2023-04-23
• Disposition First Posted: 2024-03-25
• Status Verified: 2024-04
• Disposition First Submitted: 2024-04-05
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dosage and Cohorts	agenT-797	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.

Primary Outcome Measures

Name	Time	Method
Number Of Participants With Dose-limiting Toxicities	Baseline through Month 6
Number Of Participants With Treatment-emergent Adverse Events	Baseline through Month 6

Secondary Outcome Measures

Name	Time	Method
Time To Extubation	Up to Day 30
Mean Daily Sequential Organ Failure Assessment Score	Day 30
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	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.
Change From Baseline In C-reactive Protein	Baseline through Day 30 (every 12 hours, as feasible)	C-reactive protein levels will be used to assess cytokine release syndrome.

Trial Locations

Locations (3)

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, United States