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agenT-797

Phase 1

Respiratory Distress Syndrome, Adult | Small molecule | Other |MiNK Therapeutics, Inc.|Last Updated: Dec 30, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04582201A Clinical Trial to Evaluate the Safety of agenT-797 in COVID-19 Participants With ARDSPHASE1 COMPLETED 20 — — Sep 21, 2020Apr 23, 2023Dec 30, 20253 United States
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Study Endpoints
Primary Endpoints
Number of Participants with Treatment-emergent Adverse Events
Baseline through Month 6
Number of Participants with Dose-limiting Toxicities
Baseline through Month 6
Secondary Endpoints
Time to Extubation
Up to Day 30
Change from Baseline in C-reactive Protein (CRP)
Baseline through Day 30 (every 12 hours, as feasible)
All-cause Mortality
Day 30 and Month 6
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dosage and CohortsEXPERIMENTALCohort 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.
Interventions
NameTypeDescription
agenT-797DRUGagenT-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.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Voluntarily agree to participate and ability to provide informed consent or have duly appointed health care proxy with the authority to consent. * Confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by polymerase chain reaction test or...

Countries:United States
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