COVID-19Phase 1NCT04363346
Study of FT516 for the Treatment of COVID-19 in Hospitalized Patients With Hypoxia
A Phase 1 study testing FT516 in people with COVID-19, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a Phase I study with the primary objective of identifying the maximum tolerated dose (MTD) of FT516 using 3 dose-escalation strategies (number of doses and cell dose) for the treatment of coronavirus disease 2019 (COVID-19). Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- COVID-19
- What is being tested?
- FT516
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2020to 18 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay.
- Requires hospitalization and meets the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scan)
- Able to maintain Sp02 ≥ 93% oxygen supplementation to a maximum 4L by low flow O2-delivery device at rest
- IL-6 level ≥40 pg/ml but <150 pg/mL OR CRP ≥40 mg/L (4 mg/dL) but <150 mg/L (15 mg/dL)
- Ferritin < 1000 ng/mL
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- HCT-CI score of 4 or less - For this score, if PFTs results are not available, any patient requiring oxygen prior to COVID-19 illness is not eligible
- Report of usual daily activity level (before COVID-19 illness) of Karnofsky ≥70%
- ≥ 18 years of age, but < 76 years at time of consent signing
- Females of child-bearing potential and males with partners of child-bearing potential must agree to use highly effective contraception from the time of consent and for at least 3 months after the last dose of FT516
- Agrees to and signs the separate consent for up to 15 years of follow-up on a separate LTFU companion study (IDIM-2020-28770)
- Voluntary written consent prior to the performance of any research related procedures
Who cannot join
- Any medical condition or clinical laboratory abnormality that per Investigator judgement precludes safe participation in and completion of the study, or which could affect compliance with protocol conduct or interpretation of results.
- Need for higher-percentage oxygen delivery device (face mask, oxymizer, nonrebreather, venti-mask or pressure support with CPAP/BiPAP)
- Patients with adequate oxygenation on room air
- Receiving concomitant COVID-19 directed therapy (drugs may be stopped to make patients eligible)
- Known allergy to the following FT516 components: albumin (human) or DMSO
- Any known condition that requires systemic immunosuppressive therapy (> 5mg prednisone daily or equivalent) topical and inhale steroids are permitted
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- Active autoimmune disease requiring systemic immunosuppressive therapy
- History of severe asthma and currently on chronic systemic medications (mild asthma requiring inhaled steroids only is eligible)
- Known history of HIV positivity
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Study of FT516 Safety and Feasibility for the Treatment of Coronavirus Disease 2019 (COVID-19) in Hospitalized Patients With Hypoxia
This is a Phase I study with the primary objective of identifying the maximum tolerated dose (MTD) of FT516 using 3 dose-escalation strategies (number of doses and cell dose) for the treatment of coronavirus disease 2019 (COVID-19). This study provides initial estimates of safety and efficacy based on stable respiratory function, as well as, determining the feasibility for full-scale studies designed both for efficacy and safety.
Read the detailed description
Given the urgency of COVID-19 and the known anti-viral activity of natural killer (NK) cells, this clinical trial uses immediately available off-the-shelf induced pluripotent stem cell (iPSC) derived NK cells already being used to treat cancer patients.
FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation. The investigators expect that natural developing anti-COVID IgG (early data suggest that some develop in 7-10 days after diagnosis) will enhance targeting of FT516 to infected cells.
- Conditions
- COVID-19
- Being tested
- FT516
- Keywords
- COVID-19, Corona Virus, SARS-COV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT516Drug
FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation.
| Study group | Role | What they receive |
|---|---|---|
| Dose Strategy 1 | Experimental | Dose Strategy 1:
Day 1 - FT516 is given at 9x107 cells/dose (low) Receives: Drug: FT516 |
| Dose Strategy 2 | Experimental | Dose Strategy 2:
Day 1 - FT516 is given at 9x107 cells/dose (low) + Day 4 - FT516 is given at 3x108 cells/dose (mid) Receives: Drug: FT516 |
| Dose Strategy 3 | Experimental | Dose Strategy 3:
Day 1 - FT516 is given at 9x107 cells/dose (low) + Day 4 - FT516 is given at 3x108 cells/dose (mid) + Day 7 - FT516 is given at 9x108 cells/dose (high) Receives: Drug: FT516 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose Limiting Toxicity Events
An accelerated (fast-track) design will continue until first DLT is observed or the maximum Tolerated Dose (MTD) is determined.
DLT is defined as any treatment emergent toxicity within 7 days after the last dose of FT516 meeting one of the following criteria based on CTCAE v5:
- Grade 3 or greater infusion related reaction following FT516 infusion
- Any new or worsening Grade 3 and any Grade 4 adverse events with the exception of the following known complications of COVID-19:
- Grade 3 gastrointestinal disorders (diarrhea)
- Grade 3 hepatic investigations (ALT increased, AST increased)
- Grade 3 leukopenia/lymphopenia
- Respiratory deterioration between the 1st dose and 7 days after the last dose of FT516 defined as the need for any type of assisted ventilation (invasive or non-invasive including BiPAP) or oxygen delivery device intended to deliver ≥60% FiO2 (including non-rebreather mask or >10L by simple facemask) to maintain an SpO2 >88%.
Measured: within 7 days after the last dose of FT516
Secondary outcomes (3)
The time in days from the 1st FT516 infusion to the elimination of viral shedding in nasal pharyngeal and stool samples
Measured: 36 days
The time in days from the 1st FT516 infusion to discontinued need for supplemental oxygen
Measured: 36 Days
The time in days from the 1st FT516 infusion to hospital discharge
Measured: 36 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start14 May 2020
- Primary completion18 Feb 2021
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study starts with a fast-track design by proceeding in cohorts of one patient until the first DLT is observed. If no DLT is observed, escalation continues by one patient per cohort until Dose Strategy 3 is reached. If the MTD is not yet established by Dose Strategy 3, Dose Strategy 3 is expanded to 6 patients using the final stage of a "3+3" design. An extension of 4 additional patients is planned if FT516 continues to be safe for a total of 10 patients treated at the MTD.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr.Joshua Rhein, MD, Principal investigator, Department of Medicine, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363346
- Sponsor's protocol ID
- IDIM-2020-28708
- Other IDs
- 2020LS083
- Status last verified
- Apr 2022
- First submitted
- 23 Apr 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of FT516 Safety and Feasibility for the Treatment of Coronavirus Disease 2019 (COVID-19) in Hospitalized Patients With Hypoxia
- ClinicalTrials.gov ID
- NCT04363346
- Acronym / sponsor ID
- IDIM-2020-28708
- Conditions
- COVID-19
- Keywords
- COVID-19, Corona Virus, SARS-COV-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 14 May 2020 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I study with the primary objective of identifying the maximum tolerated dose (MTD) of FT516 using 3 dose-escalation strategies (number of doses and cell dose) for the treatment of coronavirus disease 2019 (COVID-19). This study provides initial estimates of safety and efficacy based on stable respiratory function, as well as, determining the feasibility for full-scale studies designed both for efficacy and safety.
Detailed description
Given the urgency of COVID-19 and the known anti-viral activity of natural killer (NK) cells, this clinical trial uses immediately available off-the-shelf induced pluripotent stem cell (iPSC) derived NK cells already being used to treat cancer patients.
FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation. The investigators expect that natural developing anti-COVID IgG (early data suggest that some develop in 7-10 days after diagnosis) will enhance targeting of FT516 to infected cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study starts with a fast-track design by proceeding in cohorts of one patient until the first DLT is observed. If no DLT is observed, escalation continues by one patient per cohort until Dose Strategy 3 is reached. If the MTD is not yet established by Dose Strategy 3, Dose Strategy 3 is expanded to 6 patients using the final stage of a "3+3" design. An extension of 4 additional patients is planned if FT516 continues to be safe for a total of 10 patients treated at the MTD.
| Arm | Type | Receives |
|---|---|---|
| Dose Strategy 1 | Experimental | Drug: FT516Dose Strategy 1: Day 1 - FT516 is given at 9x107 cells/dose (low) |
| Dose Strategy 2 | Experimental | Drug: FT516Dose Strategy 2: Day 1 - FT516 is given at 9x107 cells/dose (low) + Day 4 - FT516 is given at 3x108 cells/dose (mid) |
| Dose Strategy 3 | Experimental | Drug: FT516Dose Strategy 3: Day 1 - FT516 is given at 9x107 cells/dose (low) + Day 4 - FT516 is given at 3x108 cells/dose (mid) + Day 7 - FT516 is given at 9x108 cells/dose (high) |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay.
- Requires hospitalization and meets the following:
- Report of usual daily activity level (before COVID-19 illness) of Karnofsky ≥70%
- ≥ 18 years of age, but < 76 years at time of consent signing
- Females of child-bearing potential and males with partners of child-bearing potential must agree to use highly effective contraception from the time of consent and for at least 3 months after the last dose of FT516
Key exclusion criteria (10 listed)
- Any medical condition or clinical laboratory abnormality that per Investigator judgement precludes safe participation in and completion of the study, or which could affect compliance with protocol conduct or interpretation of results.
- Need for higher-percentage oxygen delivery device (face mask, oxymizer, nonrebreather, venti-mask or pressure support with CPAP/BiPAP)
- Patients with adequate oxygenation on room air
- Receiving concomitant COVID-19 directed therapy (drugs may be stopped to make patients eligible)
- Known allergy to the following FT516 components: albumin (human) or DMSO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT516FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation. | Drug | Dose Strategy 1, Dose Strategy 2, Dose Strategy 3 |
Primary outcome
Number of participants with Dose Limiting Toxicity Events
Time frame: within 7 days after the last dose of FT516
An accelerated (fast-track) design will continue until first DLT is observed or the maximum Tolerated Dose (MTD) is determined. DLT is defined as any treatment emergent toxicity within 7 days after the last dose of FT516 meeting one of the following criteria based on CTCAE v5: * Grade 3 or greater infusion related reaction following FT516 infusion * Any new or worsening Grade 3 and any Grade 4 adverse events with the exception of the following known complications of COVID-19: * Grade 3 gastrointestinal disorders (diarrhea) * Grade 3 hepatic investigations (ALT increased, AST increased) * Grade 3 leukopenia/lymphopenia * Respiratory deterioration between the 1st dose and 7 days after the last dose of FT516 defined as the need for any type of assisted ventilation (invasive or non-invasive including BiPAP) or oxygen delivery device intended to deliver ≥60% FiO2 (including non-rebreather mask or >10L by simple facemask) to maintain an SpO2 >88%.
3 secondary outcomes
The time in days from the 1st FT516 infusion to the elimination of viral shedding in nasal pharyngeal and stool samples
Time frame: 36 days
The time in days from the 1st FT516 infusion to discontinued need for supplemental oxygen
Time frame: 36 Days
The time in days from the 1st FT516 infusion to hospital discharge
Time frame: 36 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Joshua Rhein, MD principal investigator
Department of Medicine, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FT516 in people with COVID-19, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose Limiting Toxicity Events (time frame: within 7 days after the last dose of FT516). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.