An Experiment to Evaluate the Safety of agenT-797 in COVID-19 Patients With Severe Difficulty Breathing.
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|ClinicalTrials.gov Identifier: NCT04582201|
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : October 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome, Adult||Drug: agenT-797||Phase 1|
This is a Phase 1 study to evaluate the safety and efficacy of agenT-797, an unmodified, allogeneic iNKT therapy, in patients with coronavirus disease 2019 (COVID-19), requiring mechanical ventilation, and with moderate to severe ARDS as determined by the Berlin definition.
The study will be conducted in 2 parts. Part 1 will employ a standard 3+3 dose escalation design of agenT-797. All patients will receive a single infusion of agent-797. Patients 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 patients in the Expansion Cohort.
Details of the analyses will be described in a statistical analysis plan.
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 (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of agenT-797 to Treat Moderate to Severe Acute Respiratory Syndrome in COVID-19 Patients|
|Actual Study Start Date :||September 21, 2020|
|Estimated Primary Completion Date :||April 24, 2021|
|Estimated Study Completion Date :||October 15, 2021|
Experimental: Dosage and Cohorts
Cohort 1 100 × 106 iNKT Cohort 2 300 × 106 iNKT Cohort 3 1000 × 106 iNKT
Dosage Frequency and Mode of Administration: agenT-797 will be administered to hospitalized patients as a single IV infusion.
agenT-797 is an off-the shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex-vivo.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 months ]Number and severity of adverse events (AEs)
- Number of Dose Limiting Toxicities [ Time Frame: 6 months ]Number of Dose Limiting Toxicities
- To assess time to improvement in pulmonary function. [ Time Frame: 30 days ]
Time to extubation.
Assessment of ventilator-free days.
Oxygenation improvement as per Berlin definition (ARDS 2012).
Supportive interventions used (e.g. use of prone ventilation, paralytics, pulmonary vasodilators, and other interventions affecting oxygenation).
- Amount of virus detected in respiratory tract samples. [ Time Frame: 30 days ]Decay in quantitative viral burden from upper and lower respiratory tract samples collected.
- To assess longevity of agenT-797 infusion. [ Time Frame: 30 days ]Persistence of allogeneic invariant natural killer T cells (iNKT) non-transduced cells.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582201
|Contact: Agenus, Inc. Clinical Trial Informationfirstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medicine New York Presbyterian||Recruiting|
|New York, New York, United States, 10022|
|Contact: Koen Van Besien, MD, PhD|
|Principal Investigator: Koen Van Besien, MD|
|Study Director:||Medical Director||Agenus Inc.|