Acute Respiratory Distress SyndromePhase 2NCT07492888

Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or Without Sepsis/ARDS)

A Phase 2 study testing Nogapendekin Alfa-Inbakicept (NAI) and Allogeneic invariant Natural Killer T (iNKT) Cells (AgenT-797) in people with Acute Respiratory Distress Syndrome and Severe Community-Acquired Pneum, run by ImmunityBio, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This Phase 2 study tests whether adding two immune therapies - nogapendekin alfa-inbakicept (NAI) and off-the-shelf iNKT cell infusions - to standard care can safely help critically ill adults with severe community-acquired pneumonia (CAP) (with or without sepsis/ARDS) recover. Read more about this study

Who is it for?: Ages 18 to 105 years
Conditions the study is for: Acute Respiratory Distress Syndrome, Severe Community-Acquired Pneum, Sepsis
What is being tested?: Nogapendekin Alfa-Inbakicept (NAI) and Allogeneic invariant Natural Killer T (iNKT) Cells (AgenT-797)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 15 Apr 2026to 15 Jan 2027
Phase: Phase 2
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 105 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years.
Critically ill adult requiring ICU admission due to severe community acquired pneumonia (CAP), defined by ≥1 major criterion or ≥3 minor criteria (IDSA/ATS):
Major: respiratory failure requiring mechanical ventilation OR septic shock requiring vasopressors.
Minor: tachypnea (RR ≥ 30), PaO2/FiO2 ≤ 200, multilobar infiltrates, new confusion/disorientation, BUN ≥ 20 mg/dL, platelet count < 100,000/µL, core temperature < 36.0°C, hypotension requiring aggressive fluid resuscitation.
Hospital admission with diagnosis of CAP within 72 hours.
Lymphopenia: absolute lymphocyte count (ALC) < 1,500/µL (not secondary to chemotherapy).
Receiving antibiotics for CAP (at least one dose since ICU admission).
Informed consent obtainable from participant or legally authorized representative.

Who cannot join

Hematologic malignancy (e.g., active leukemia or lymphoma not in remission).
Post CAR T therapy or hematopoietic cell transplant for ALL, NHL, or multiple myeloma < 3 months prior to enrollment.
Current diagnosis of cytokine release syndrome.
Receiving colony stimulating factors (e.g., G CSF).
Clinical history or imaging suggesting aspiration of gastric contents.
Advanced dementia or prolonged bedridden status.

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Pregnancy or breastfeeding.
High dose immunosuppressive therapy at baseline (e.g., > 0.5 mg/kg prednisone or equivalent). (Low dose corticosteroids for septic shock/ARDS per SOC permitted.)
Uncontrolled autoimmune or inflammatory disease requiring immunosuppressive therapies.
Life expectancy < 24-48 hours or moribund condition despite care (investigator judgment).
Active uncontrolled bleeding or intracerebral hemorrhage.
Known hypersensitivity to ingredients used in the cell product formulation (e.g., DMSO).
Treated by antibiotics for the current respiratory infection for more than seven days at time of hospitalization (unless culture/sensitivity indicates resistant organism to administered antibiotics).
Known active viral hepatitis A, B, or C.
Investigator judgment that participation is not in the participant's best interest or participant is unsuitable for enrollment.

About this study

Official title: Phase 2 Study Evaluating Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia With or Without Sepsis/Acute Respiratory Distress Syndrome.

Read the detailed description

Phase 2, single-arm study in up to 20 critically ill adults with severe community-acquired pneumonia (CAP) (with or without sepsis/ARDS) and lymphopenia (ALC <1,500/µL). The study evaluates the safety, tolerability, and preliminary efficacy of combining an IL-15 superagonist (nogapendekin alfa-inbakicept, NAI) with an allogeneic invariant natural killer T cell product (iNKT cells) added to standard ICU care.

Key elements

Population: Adults (≥18) admitted to ICU for severe CAP within 72 hours, meeting IDSA/ATS severe CAP criteria (≥1 major or ≥3 minor) and on antibiotics.

Planned enrollment: up to 20 participants (≈40 screened).

Intervention schedule:

Day 1: NAI subcutaneous (≤50 kg → 15 µg/kg; >50 kg → fixed 1 mg). Day 3: Single IV infusion of iNKT cells (1 × 10^9 cells). Day 10: Second NAI subcutaneous dose (same dosing as Day 1). Concomitant care: all participants receive guideline-based standard of care for CAP/sepsis/ARDS (antibiotics, organ support, lung-protective ventilation, vasopressors, low-dose steroids as indicated, etc.).

Safety oversight: continuous ICU monitoring; Sponsor Drug Safety review of SAEs; Safety Review Committee (SRC) reviews safety after first 5 participants and oversees stopping rules. Predefined toxicity rules and management algorithms for infusion reactions, CRS, and ICANS are specified.

Primary endpoints: safety/tolerability (TEAEs, SAEs, grade ≥3 AEs) and 28-day all-cause mortality.

Secondary endpoints: absolute lymphocyte count recovery, ventilator-free days, ICU-free days, antibiotic-free days, days free from organ support, time to ICU/hospital discharge, incidence of secondary infections through Day 28, and 90-day mortality.

Exploratory endpoints: serum cytokines, NK and T-cell expansion and activation/exhaustion markers, monocyte HLA-DR, quantification and persistence of donor iNKT cells (Days 1, 7, 14, 28).

Duration per participant: treatment up to 10 days; follow-up to 90 days after first dose.

Stopping/discontinuation: specified criteria for permanent discontinuation (e.g., drug-related Grade ≥3 organ toxicity, Grade ≥3 CRS/ICANS, intolerable infusion reactions), SRC stopping rules (including treatment-related death or clustered severe toxicities).

Objective: determine whether the NAI + iNKT combination can be given safely in this population and provide signals of reduced 28-day mortality and immune recovery (reversal of lymphopenia) to justify further study.

Sites will collect clinical outcomes, safety data, laboratory panels (CBC/CMP/coagulation), and samples for immune monitoring per protocol schedule.

Conditions: Acute Respiratory Distress Syndrome, Severe Community-Acquired Pneum, Sepsis, Lymphopenia / Immunoparalysis in Critically Ill Adults
Being tested: Nogapendekin Alfa-Inbakicept (NAI), Allogeneic invariant Natural Killer T (iNKT) Cells (AgenT-797)
Keywords: nogapendekin alfa-inbakicept, NAI, ANKTIVA, iNKT cells, AgenT-797, IL-15 superagonist, cell therapy, immunotherapy, community-acquired pneumonia, CAP, sepsis, sepsis shock, acute respiratory distress syndrome, ARDS, lymphopenia, immunoparalysis, intensive care unit, ICU, critical care, ventilator-free days
Medical subject headings: Respiratory Distress Syndrome, Sepsis, Lymphopenia, Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nogapendekin Alfa-Inbakicept (NAI)Drug
Also called Anktiva, N-803, ALT-803
Nogapendekin alfa-inbakicept (NAI) - a recombinant IL-15 superagonist complex (IL-15N72D:IL-15RαSu/IgG1 Fc) administered subcutaneously (Day 1 and Day 10; weight-based 15 µg/kg if ≤50 kg or fixed 1 mg if >50 kg) to stimulate NK and CD8+ T-cell proliferation and function.
Allogeneic invariant Natural Killer T (iNKT) Cells (AgenT-797)Drug
Allogeneic invariant Natural Killer T (iNKT) Cells (AgenT-797) - cryopreserved, GMP-manufactured off-the-shelf donor iNKT cell product administered as a single intravenous infusion (1 × 10^9 cells on Day 3) intended to provide immediate effector function and immunomodulation; cell product thawed and infused per cell-therapy procedures with premedication as indicated.

Study groups in NCT07492888
Study group	Role	What they receive
NAI Plus iNKT Cells With Standard of Care	Experimental	Single-arm treatment: all participants receive nogapendekin alfa-inbakicept (NAI) plus a single infusion of allogeneic iNKT cells in addition to guideline-based standard of care. NAI SC on Day 1 and Day 10 (≤50 kg: 15 µg/kg; >50 kg: fixed 1 mg). iNKT cells IV single dose on Day 3 (1 × 10^9 cells). Standard ICU care (antibiotics, ventilation/organ support, vasopressors, low-dose steroids as indicated) provided per site. Continuous safety monitoring with SRC review after first 5 participants. Receives: Drug: Nogapendekin Alfa-Inbakicept (NAI); Drug: Allogeneic invariant Natural Killer T (iNKT) Cells (AgenT-797)

What is being measured

The primary outcome is the main question the study is designed to answer.

28-day all-cause mortality
Proportion of participants who die from any cause within 28 days of first study drug administration.
Measured: Day 28 (28 days after first dose)
Treatment Emergent Adverse Events (TEAEs)
Any new or worsening medical event beginning after the first dose through 30 days post-last dose, collected to characterize overall tolerability.
Measured: From first study treatment to 30 days after the participant's last study dose.
Severe Adverse Events (SAEs)
Events meeting regulatory seriousness criteria (death, life-threatening, hospitalization, disability, congenital anomaly or other medically important events) reported to evaluate major safety risks.
Measured: From first study treatment to 30 days after the participant's last study dose (SAEs related to study product reported regardless of last dose date).
Grade ≥3 TEAEs
Adverse events of CTCAE severity grade 3 or higher that emerge after first dose, used to quantify severe toxicity burden.
Measured: From first study treatment to 30 days after the participant's last study dose.
Safety laboratory tests
Routine clinical labs (CBC, chemistry, coagulation, etc.) collected serially to detect clinically meaningful laboratory abnormalities attributable to treatment.
Measured: From baseline (pre-dose) through 30 days after the participant's last study dose.
Temperature
Serial core body temperature measured in degrees Celsius. Report baseline, maximum post-dose within 24 hours, and incidence of fever >39.0°C.
Measured: Baseline (pre-dose) through End of ICU stay; intensified monitoring for 24 hours after iNKT infusion (vitals every ≥4 hours; continuous telemetry as indicated).
Heart rate
Serial heart rate (bpm). Report baseline, peak within 24 hours post-infusion, and incidence of new clinically significant tachycardia (>120 bpm) requiring intervention.
Measured: Baseline (pre-dose); maximum post-dose within 24 hours after iNKT infusion (intensified monitoring during this 24-hour window); overall reporting through End of ICU stay (up to 28 days).
Blood pressure
Serial systolic/diastolic blood pressure (mmHg). Report baseline, nadir within 24 hours post-infusion, and incidence of new hypotension (MAP <65 mmHg or need for new/increased vasopressor) temporally related to infusion.
Measured: Baseline (pre-dose); maximum post-dose within 24 hours after iNKT infusion (intensified monitoring during this 24-hour window); overall reporting through End of ICU stay (up to 28 days).
Respiratory rate
Serial RR (breaths/min). Report baseline, worst value within 24 hours post-infusion, and incidence of clinically significant tachypnea (RR ≥30) or new respiratory deterioration requiring escalation.
Measured: Baseline (pre-dose); maximum post-dose within 24 hours after iNKT infusion (intensified monitoring during this 24-hour window); overall reporting through End of ICU stay (up to 28 days).
Oxygen saturation
Serial peripheral oxygen saturation (%). Report baseline, nadir within 24 hours post-infusion, and incidence of new hypoxemia (SpO2 <90% on prior baseline support or increase in FiO2/ventilatory support).
Measured: Baseline through End of ICU stay; intensified monitoring for 24 hours after iNKT infusion.

Secondary outcomes (10)

Absolute Lymphocyte Count (ALC)
Peripheral ALC measured over time to evaluate reversal of lymphopenia and quantitative immune recovery after treatment.
Measured: Assessed at baseline and summarized at Days 7, 14, 21, and 28 after first dose.
Ventilator-free days (VFD) through Day 28
From first study treatment through Day 28 after first dose.
Measured: Number of days within the 28-day window the participant is alive and free from mechanical ventilation, with death or ventilator dependence to Day 28 scored as zero.
ICU-free days through Day 28
Number of days within 28 days the participant is alive and not in ICU, reflecting time free from intensive care support.
Measured: From first study treatment through Day 28 after first dose.
Antibiotic-free days through Day 28
Number of days within 28 days the participant is alive and not receiving systemic antibiotics for respiratory infection, as a proxy for infection control and clinical recovery.
Measured: From first study treatment through Day 28 after first dose.
Days alive and free of other organ support through Day 28
Count of days within 28 days the participant is alive and not requiring non-respiratory organ supports (eg, vasopressors, renal replacement therapy), reflecting multi-organ recovery.
Measured: From first study treatment through Day 28 after first dose.
Time to ICU discharge
Interval from first dose to date/time participant leaves ICU, used to assess speed of clinical improvement sufficient for lower-level care.
Measured: From first study treatment (Day 1) through Day 28 - time to ICU discharge will be reported as days from first dose to date/time of ICU discharge; participants not discharged by Day 28 will be censored at Day 28.
Time to hospital discharge
From first study treatment until hospital discharge (if occurs).
Measured: From first study treatment (Day 1) through Day 28 - time to hospital discharge will be reported as days from first dose to date of hospital discharge; participants not discharged by Day 28 will be censored at Day 28.
Number of secondary infections through Day 28
Incidence and timing of new clinically documented infections (eg, ventilator-associated pneumonia, bloodstream infection) occurring within 28 days, to evaluate infection risk post-treatment.
Measured: From first study treatment through Day 28 after first dose.
Number of secondary infections through participant follow-up
From first study treatment through 90 days after first dose.
Measured: Incidence of new clinically documented infections up to 90 days to capture later-onset infectious complications.
90-day all-cause mortality
Death from any cause occurring within 90 days of first treatment to evaluate longer-term survival.
Measured: From first study treatment to Day 90 after first dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 202615 Jan 2027

First posted25 Mar 2026
Study start15 Apr 2026 (estimated)
Primary completion15 Nov 2026 (estimated)
Study completion15 Jan 2027 (estimated)

Why it stopped: New protocol developed

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
More trials run by ImmunityBio, Inc.The 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Open-label, single-arm study in which all enrolled participants receive nogapendekin alfa-inbakicept (NAI) plus a single IV infusion of allogeneic iNKT cells added to standard of care. Participants receive NAI on Days 1 and 10 and iNKT cells on Day 3; safety review by the SRC after the first 5 participants. Up to 20 participants will be treated and followed for 90 days.
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07492888
Sponsor's protocol ID: ResQ219-CAP
Status last verified: May 2026
First submitted: 13 Mar 2026
Last updated: 8 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Study Evaluating Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia With or Without Sepsis/Acute Respiratory Distress Syndrome.
ClinicalTrials.gov ID: NCT07492888
Acronym / sponsor ID: ResQ219-CAP
Conditions: Acute Respiratory Distress Syndrome, Severe Community-Acquired Pneum, Sepsis, Lymphopenia / Immunoparalysis in Critically Ill Adults
Keywords: nogapendekin alfa-inbakicept, NAI, ANKTIVA, iNKT cells, AgenT-797, IL-15 superagonist, cell therapy, immunotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: New protocol developed
Enrolment: 0 participants (actual)
Lead sponsor: ImmunityBio, Inc.Industry (pharma, biotech, devices)
Study start: 15 Apr 2026 (estimated)
Primary completion: 15 Nov 2026 (estimated)
Study completion: 15 Jan 2027 (estimated)
First posted: 25 Mar 2026 (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.

Detailed description

Key elements

Population: Adults (≥18) admitted to ICU for severe CAP within 72 hours, meeting IDSA/ATS severe CAP criteria (≥1 major or ≥3 minor) and on antibiotics.

Planned enrollment: up to 20 participants (≈40 screened).

Intervention schedule:

Primary endpoints: safety/tolerability (TEAEs, SAEs, grade ≥3 AEs) and 28-day all-cause mortality.

Exploratory endpoints: serum cytokines, NK and T-cell expansion and activation/exhaustion markers, monocyte HLA-DR, quantification and persistence of donor iNKT cells (Days 1, 7, 14, 28).

Duration per participant: treatment up to 10 days; follow-up to 90 days after first dose.

Sites will collect clinical outcomes, safety data, laboratory panels (CBC/CMP/coagulation), and samples for immune monitoring per protocol schedule.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open-label, single-arm study in which all enrolled participants receive nogapendekin alfa-inbakicept (NAI) plus a single IV infusion of allogeneic iNKT cells added to standard of care. Participants receive NAI on Days 1 and 10 and iNKT cells on Day 3; safety review by the SRC after the first 5 participants. Up to 20 participants will be treated and followed for 90 days.

Arm	Type	Receives
NAI Plus iNKT Cells With Standard of Care	Experimental	Drug: Nogapendekin Alfa-Inbakicept (NAI), Drug: Allogeneic invariant Natural Killer T (iNKT) Cells (AgenT-797)Single-arm treatment: all participants receive nogapendekin alfa-inbakicept (NAI) plus a single infusion of allogeneic iNKT cells in addition to guideline-based standard of care. NAI SC on Day 1 and Day 10 (≤50 kg: 15 µg/kg; >50 kg: fixed 1 mg). iNKT cells IV single dose on Day 3 (1 × 10^9 cells). Standard ICU care (antibiotics, ventilation/organ support, vasopressors, low-dose steroids as indicated) provided per site. Continuous safety monitoring with SRC review after first 5 participants.

Who may qualify

Ages: 18 to 105 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age ≥ 18 years.
Critically ill adult requiring ICU admission due to severe community acquired pneumonia (CAP), defined by ≥1 major criterion or ≥3 minor criteria (IDSA/ATS):
Hospital admission with diagnosis of CAP within 72 hours.
Lymphopenia: absolute lymphocyte count (ALC) < 1,500/µL (not secondary to chemotherapy).
Receiving antibiotics for CAP (at least one dose since ICU admission).

Key exclusion criteria (15 listed)

Hematologic malignancy (e.g., active leukemia or lymphoma not in remission).
Post CAR T therapy or hematopoietic cell transplant for ALL, NHL, or multiple myeloma < 3 months prior to enrollment.
Current diagnosis of cytokine release syndrome.
Receiving colony stimulating factors (e.g., G CSF).
Clinical history or imaging suggesting aspiration of gastric contents.

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
Nogapendekin Alfa-Inbakicept (NAI)Also: Anktiva, N-803, ALT-803Nogapendekin alfa-inbakicept (NAI) - a recombinant IL-15 superagonist complex (IL-15N72D:IL-15RαSu/IgG1 Fc) administered subcutaneously (Day 1 and Day 10; weight-based 15 µg/kg if ≤50 kg or fixed 1 mg if >50 kg) to stimulate NK and CD8+ T-cell proliferation and function.	Drug	NAI Plus iNKT Cells With Standard of Care
Allogeneic invariant Natural Killer T (iNKT) Cells (AgenT-797)Allogeneic invariant Natural Killer T (iNKT) Cells (AgenT-797) - cryopreserved, GMP-manufactured off-the-shelf donor iNKT cell product administered as a single intravenous infusion (1 × 10^9 cells on Day 3) intended to provide immediate effector function and immunomodulation; cell product thawed and infused per cell-therapy procedures with premedication as indicated.	Drug	NAI Plus iNKT Cells With Standard of Care

Primary outcome

28-day all-cause mortality
Time frame: Day 28 (28 days after first dose)
Proportion of participants who die from any cause within 28 days of first study drug administration.
Treatment Emergent Adverse Events (TEAEs)
Time frame: From first study treatment to 30 days after the participant's last study dose.
Any new or worsening medical event beginning after the first dose through 30 days post-last dose, collected to characterize overall tolerability.
Severe Adverse Events (SAEs)
Time frame: From first study treatment to 30 days after the participant's last study dose (SAEs related to study product reported regardless of last dose date).
Events meeting regulatory seriousness criteria (death, life-threatening, hospitalization, disability, congenital anomaly or other medically important events) reported to evaluate major safety risks.
Grade ≥3 TEAEs
Time frame: From first study treatment to 30 days after the participant's last study dose.
Adverse events of CTCAE severity grade 3 or higher that emerge after first dose, used to quantify severe toxicity burden.
Safety laboratory tests
Time frame: From baseline (pre-dose) through 30 days after the participant's last study dose.
Routine clinical labs (CBC, chemistry, coagulation, etc.) collected serially to detect clinically meaningful laboratory abnormalities attributable to treatment.
Temperature
Time frame: Baseline (pre-dose) through End of ICU stay; intensified monitoring for 24 hours after iNKT infusion (vitals every ≥4 hours; continuous telemetry as indicated).
Serial core body temperature measured in degrees Celsius. Report baseline, maximum post-dose within 24 hours, and incidence of fever >39.0°C.
Heart rate
Time frame: Baseline (pre-dose); maximum post-dose within 24 hours after iNKT infusion (intensified monitoring during this 24-hour window); overall reporting through End of ICU stay (up to 28 days).
Serial heart rate (bpm). Report baseline, peak within 24 hours post-infusion, and incidence of new clinically significant tachycardia (>120 bpm) requiring intervention.
Blood pressure
Time frame: Baseline (pre-dose); maximum post-dose within 24 hours after iNKT infusion (intensified monitoring during this 24-hour window); overall reporting through End of ICU stay (up to 28 days).
Serial systolic/diastolic blood pressure (mmHg). Report baseline, nadir within 24 hours post-infusion, and incidence of new hypotension (MAP <65 mmHg or need for new/increased vasopressor) temporally related to infusion.
Respiratory rate
Time frame: Baseline (pre-dose); maximum post-dose within 24 hours after iNKT infusion (intensified monitoring during this 24-hour window); overall reporting through End of ICU stay (up to 28 days).
Serial RR (breaths/min). Report baseline, worst value within 24 hours post-infusion, and incidence of clinically significant tachypnea (RR ≥30) or new respiratory deterioration requiring escalation.
Oxygen saturation
Time frame: Baseline through End of ICU stay; intensified monitoring for 24 hours after iNKT infusion.
Serial peripheral oxygen saturation (%). Report baseline, nadir within 24 hours post-infusion, and incidence of new hypoxemia (SpO2 <90% on prior baseline support or increase in FiO2/ventilatory support).

10 secondary outcomes

Absolute Lymphocyte Count (ALC)
Time frame: Assessed at baseline and summarized at Days 7, 14, 21, and 28 after first dose.
Ventilator-free days (VFD) through Day 28
Time frame: Number of days within the 28-day window the participant is alive and free from mechanical ventilation, with death or ventilator dependence to Day 28 scored as zero.
ICU-free days through Day 28
Time frame: From first study treatment through Day 28 after first dose.
Antibiotic-free days through Day 28
Time frame: From first study treatment through Day 28 after first dose.
Days alive and free of other organ support through Day 28
Time frame: From first study treatment through Day 28 after first dose.
Time to ICU discharge
Time frame: From first study treatment (Day 1) through Day 28 - time to ICU discharge will be reported as days from first dose to date/time of ICU discharge; participants not discharged by Day 28 will be censored at Day 28.
Time to hospital discharge
Time frame: From first study treatment (Day 1) through Day 28 - time to hospital discharge will be reported as days from first dose to date of hospital discharge; participants not discharged by Day 28 will be censored at Day 28.
Number of secondary infections through Day 28
Time frame: From first study treatment through Day 28 after first dose.
Number of secondary infections through participant follow-up
Time frame: Incidence of new clinically documented infections up to 90 days to capture later-onset infectious complications.
90-day all-cause mortality
Time frame: From first study treatment to Day 90 after first dose.

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
Individual participant dataSharing planned: Undecided

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 15 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: withdrawn, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

28-day all-cause mortality (time frame: Day 28 (28 days after first dose)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07492888.

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 8 May 2026.