A Clinical Trial to Evaluate the Safety of agenT-797 in COVID-19 Participants With ARDS
NCT ID: NCT04582201
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2020-09-21
2023-04-23
Brief Summary
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Detailed Description
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The study will be conducted in 2 parts. 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 principal investigator. Once the maximum tolerated dose of agenT-797 has been cleared in Part 1, Part 2 of the study will be opened and enroll eligible participants in the Expansion Cohort.
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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dosage and Cohorts
Cohort 1: 100 × 10\^6 iNKT cells; Cohort 2: 300 × 10\^6 iNKT cells; Cohort 3: 1000 × 10\^6 iNKT cells
Dosage Frequency and Mode of Administration: agenT-797 will be administered to hospitalized participants as a single intravenous infusion.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by polymerase chain reaction test or equivalent approved test.
* Inpatient hospitalization.
* Evidence of SARS-CoV-2 infection with the diagnosis of moderate to severe ARDS per Berlin definition, no more than 2 weeks prior to study enrollment.
* Participants, or duly appointed health care proxy with the authority to consent, must consent to placement of a central venous access line for the administration of agenT-797.
Exclusion Criteria
* Presence of comorbidities limiting expected survival of \<1 month.
* Any comorbidity which in the opinion of the investigator may preclude/confound study required safety and efficacy assessments.
* Clinically significant cardiomyopathy.
* Receipt of non-oncology vaccines containing live virus for prevention of infectious diseases within 4 weeks prior to first dose of study treatment.
* Known hypersensitivity to natural killer cells or their preservation solution.
* Active systemic bacterial or fungal infection or viral co-infection.
* Legally incapacitated or has limited legal capacity.
* Pregnant or lactating women.
18 Years
ALL
No
Sponsors
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MiNK Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
MiNK Therapeutics
Locations
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Saint John's Cancer Institute
Santa Monica, California, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States
Weill Cornell Medicine New York Presbyterian
New York, New York, United States
Countries
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Other Identifiers
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C-1300-01
Identifier Type: -
Identifier Source: org_study_id