Community-Acquired Pneumonia (CAP)Phase 3NCT07492875
Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia
A Phase 3 study testing Nogapendekin alfa inbakicept (NAI) and agenT-797 in people with Community-Acquired Pneumonia (CAP) and Acute Respiratory Distress Syndrome (ARDS), run by ImmunityBio, Inc..
Trial summary
This is a Phase 3, randomized, blinded, and placebo-controlled clinical trial investigating a new combination treatment for critically ill adults who have severe community-acquired pneumonia, especially if they also have sepsis or acute respiratory distress syndrome. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Community-Acquired Pneumonia (CAP), Acute Respiratory Distress Syndrome (ARDS), Sepsis
- What is being tested?
- Nogapendekin alfa inbakicept (NAI) and agenT-797
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 31 Dec 2029
- Phase
- Phase 3
- 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, adult participants of any gender.
- Critically ill adults requiring admission to an ICU-unit due to severe community acquired pneumonia.
- Severe CAP is defined by the presence of one major criterion or at least three minor criteria:
- Major Criteria (any one = severe CAP):
- Respiratory failure requiring mechanical ventilation
- Septic shock requiring vasopressors to maintain blood pressure
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- Minor Criteria (≥3 indicates severe CAP):
- Tachypnea: Respiratory rate ≥ 30 breaths/min
- Hypoxemia: PaO2/FiO2 ratio ≤ 200
- Multilobar infiltrates on chest imaging
- Confusion or disorientation (new onset mental status changes)
- Uremia: Blood urea nitrogen (BUN) ≥ 20 mg/dL (7.1 mmol/L)
- Thrombocytopenia: Platelet count < 100,000/μL
- Hypothermia: Core temperature < 36.0 °C (96.8 °F)
- Hypotension requiring aggressive fluid resuscitation
- Hospital admission with a diagnosis of CAP within 72 hours.
- Lymphopenia/ Absolute Lymphocyte Count (ALC): ALC < 1,500/μL (not secondary due to chemotherapy).
- Participants already treated by antibiotics (at least one dose since admission to the ICU).
- Informed consent: Ability to obtain informed consent from participant or legally authorized representative (given the incapacity of many ICU participants, consent via surrogate/Legally Authorized Representative is allowed per ethics approval).
Who cannot join
- Hematologic malignancies (eg, active leukemia and lymphoma, not in remission).
- Post CAR-T cells therapy or hematopoietic cell transplant for ALL, NHL or Multiple Myeloma less than 3 months prior to enrollment.
- Participant diagnosed with cytokine release syndrome.
- Participant receiving colony stimulating factors eg, G-CSF.
- Clinical history or radiological imaging suggesting aspiration of gastric content.
- Participant with advanced dementia or prolonged bedridden status.
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- Pregnancy or breastfeeding.
- High-dose immunosuppressive therapy at baseline: eg, > 0.5 mg/kg prednisone (or equivalent). Note: Use of low-dose corticosteroids for septic shock or ARDS (eg, dexamethasone 6 mg/day for ARDS) is not an exclusion, as it is standard care such use will be recorded and balanced between arms.
- Uncontrolled autoimmune or inflammatory disease requiring immunosuppressive therapies (to avoid confounding immune effects or exacerbation).
- Life expectancy < 24-48 hours or moribund condition despite care (Investigator judgment that participant will not survive long enough to benefit or be evaluated).
- Active uncontrolled bleeding or intracerebral hemorrhage (cell therapy infusion could transiently affect hemodynamics or coagulation; exclude if such conditions make the intervention risk unjustifiable).
- Known hypersensitivity to ingredients used in cell product formulation such as DMSO.
- Treated by antibiotics for a respiratory infection for more than seven days at the time of hospitalization (except if culture and sensitivities determine a resistant organism to the administered antibiotics).
- Known active Viral Hepatitis A, B, or C.
- History of human immunodeficiency virus (HIV) with current CD4+ T-cell count < 350 cells/µL and/or a detectable HIV viral load.
- The Investigator believes that participating in the trial is not in the best interest of the participant, or the Investigator considers the participant unsuitable for enrollment (such as due to unpredictable risks or severe co-morbidities).
About this study
Official title: Phase 3 Randomized, Blinded, Placebo-Controlled 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
This is a Phase 3, randomized, blinded, and placebo-controlled clinical trial investigating a new combination treatment for critically ill adults who have severe community-acquired pneumonia, especially if they also have sepsis or acute respiratory distress syndrome.
The study aims to determine if adding the experimental agents, Nogapendekin Alfa Inbakicept and iNKT cells, to standard medical care can reduce the 28-day all-cause mortality rate compared to standard care alone with a placebo.
Read the detailed description
This multi-center, randomized, blinded, and placebo-controlled Phase 3 study aims to address the high mortality and complication rates associated with severe community-acquired pneumonia (CAP) in critically ill adults, particularly those experiencing immune deficiency like lymphopenia or immunoparalysis.
Current standard treatments for severe CAP focus on infection control and organ support but often do not directly restore the patient's compromised immune function. This trial investigates a novel immunotherapeutic approach using a combination of two agents:
- Nogapendekin Alfa Inbakicept (NAI): An IL-15 receptor agonist designed to activate natural killer (NK) and CD8+ T-cells, aiming to enhance the body's immune competence.
- iNKT Cells (invariant natural killer T cells): An allogeneic cell therapy intended to rapidly orchestrate both innate and adaptive immune responses.
The central hypothesis is that this combination therapy, when added to standard of care treatments, can reverse immune dysfunction, clear infections, regulate inflammation, and ultimately improve survival and reduce severe complications such as secondary infections and prolonged organ support requirements in this vulnerable patient population. The study will meticulously assess the safety and efficacy of this combined approach, building on promising signals from earlier research.
- Conditions
- Community-Acquired Pneumonia (CAP), Acute Respiratory Distress Syndrome (ARDS), Sepsis, Lymphopenia, Immunoparalysis
- Being tested
- Nogapendekin alfa inbakicept (NAI), agenT-797
- Keywords
- Community-Acquired Pneumonia, Severe CAP, Sepsis, Acute Respiratory Distress Syndrome (ARDS), Nogapendekin Alfa Inbakicept (NAI), ANKTIVA, iNKT Cells, Invariant Natural Killer T cells (AgenT-797), Immunotherapy, Immunomodulation, Lymphopenia, Critical Illness, Randomized Controlled Trial, Phase 3
- Medical subject headings
- Community-Acquired Pneumonia, Respiratory Distress Syndrome, Sepsis, Lymphopenia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nogapendekin alfa inbakicept (NAI)Biological
NAI is a soluble complex consisting of two protein subunits of a human IL-15 variant (nogapendekin alfa) bound with high affinity to a dimeric human IL 15Rα sushi domain/human IgG1 Fc fusion protein (inbakicept).
agenT-797Biological
Allogeneic invariant NKT (iNKT) cell therapy - an off-the-shelf cell therapy that can rapidly orchestrate both innate and adaptive immunity.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Participants in this arm receive the investigational treatments: Nogapendekin Alfa Inbakicept (NAI) administered subcutaneously on Day 1 and Day 10, and iNKT cells administered intravenously on Day 3. All participants also receive standard of care (SOC) treatments for severe community-acquired pneumonia, with or without sepsis/ARDS. Receives: Biological: Nogapendekin alfa inbakicept (NAI) |
| Control Arm | Placebo comparator | Participants in this arm receive placebos matching the investigational treatments: a subcutaneous placebo on Day 1 and Day 10, and an intravenous placebo on Day 3. All participants also receive standard of care (SOC) treatments for severe community-acquired pneumonia, with or without sepsis/ARDS. Receives: Biological: agenT-797 |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
Up to Day 28 from randomization. (Participants lost to follow-up before Day 28 will be censored at their last known date alive; participants alive on Day 28 will be censored at Day 28).
Measured: 30 days after the last dose of study drug
Secondary outcomes (9)
ALC count
Absolute Lymphocyte Count
Measured: From randomization through 28 days following randomization.
Ventilator-Free days (VFD) through Day 28.
The number of days a participant is free from mechanical ventilation.
Measured: Through 28 days following randomization.
Number of ICU free days through Day 28.
The number of days a participant is free from being in the Intensive Care Unit.
Measured: Through 28 days following randomization.
Number of antibiotic free days through Day 28.
The number of days a participant is free from antibiotic treatment.
Measured: Through 28 days following randomization.
Number of days alive and free of organ support through 28 days.
The number of days a participant is alive and does not require organ support.
Measured: Through 28 days following randomization.
Time from first administration of study drug to ICU discharge.
The duration from the first dose of study drug until the participant is discharged from the Intensive Care Unit.
Measured: From first study drug administration until ICU discharge, assessed up to 90 days; ICU discharge date documented from medical record (participants not discharged by Day 90 censored at Day 90; deaths prior to discharge counted as competing events).
Time from first administration of study drug to hospital discharge.
The duration from the first dose of study drug until the participant is discharged from the hospital.
Measured: From first study drug administration until hospital discharge, assessed up to 90 days; hospital discharge date documented from medical record (participants not discharged by Day 90 censored at Day 90; deaths prior to discharge counted as competing events
Incidence of secondary infections through Day 28 and for the entire study.
The occurrence rate of infections that develop after the start of study treatment.
Measured: From randomization through 90 days following randomization.
90-day all-cause mortality.
Death from any cause.
Measured: Through 90 days following randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Apr 2029 (estimated)
- Study completion31 Dec 2029 (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 Community-Acquired Pneumonia (CAP)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel assignment study where participants are randomized 1:1 into two distinct arms: an Experimental Arm receiving active study drugs (Nogapendekin Alfa Inbakicept and iNKT cells) plus standard of care, and a Control Arm receiving matching placebos plus standard of care. The study is double-blinded, meaning both participants and treating physicians are unaware of the assigned treatment to maintain objectivity. Blinding is maintained through the use of identical-appearing syringes for NAI/placebo and identical IV bags for iNKT cells/placebo.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jayson Garmizo, Study director, ImmunityBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492875
- Sponsor's protocol ID
- ResQ218B-CAP
- Status last verified
- Mar 2026
- First submitted
- 18 Sep 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 3 Randomized, Blinded, Placebo-Controlled 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
- NCT07492875
- Acronym / sponsor ID
- ResQ218B-CAP
- Conditions
- Community-Acquired Pneumonia (CAP), Acute Respiratory Distress Syndrome (ARDS), Sepsis, Lymphopenia, Immunoparalysis
- Keywords
- Community-Acquired Pneumonia, Severe CAP, Sepsis, Acute Respiratory Distress Syndrome (ARDS), Nogapendekin Alfa Inbakicept (NAI), ANKTIVA, iNKT Cells, Invariant Natural Killer T cells (AgenT-797)
- Phase
- Phase 3
- 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 Apr 2029 (estimated)
- Study completion
- 31 Dec 2029 (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.
This is a Phase 3, randomized, blinded, and placebo-controlled clinical trial investigating a new combination treatment for critically ill adults who have severe community-acquired pneumonia, especially if they also have sepsis or acute respiratory distress syndrome.
The study aims to determine if adding the experimental agents, Nogapendekin Alfa Inbakicept and iNKT cells, to standard medical care can reduce the 28-day all-cause mortality rate compared to standard care alone with a placebo.
Detailed description
This multi-center, randomized, blinded, and placebo-controlled Phase 3 study aims to address the high mortality and complication rates associated with severe community-acquired pneumonia (CAP) in critically ill adults, particularly those experiencing immune deficiency like lymphopenia or immunoparalysis.
Current standard treatments for severe CAP focus on infection control and organ support but often do not directly restore the patient's compromised immune function. This trial investigates a novel immunotherapeutic approach using a combination of two agents:
- Nogapendekin Alfa Inbakicept (NAI): An IL-15 receptor agonist designed to activate natural killer (NK) and CD8+ T-cells, aiming to enhance the body's immune competence.
- iNKT Cells (invariant natural killer T cells): An allogeneic cell therapy intended to rapidly orchestrate both innate and adaptive immune responses.
The central hypothesis is that this combination therapy, when added to standard of care treatments, can reverse immune dysfunction, clear infections, regulate inflammation, and ultimately improve survival and reduce severe complications such as secondary infections and prolonged organ support requirements in this vulnerable patient population. The study will meticulously assess the safety and efficacy of this combined approach, building on promising signals from earlier research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a parallel assignment study where participants are randomized 1:1 into two distinct arms: an Experimental Arm receiving active study drugs (Nogapendekin Alfa Inbakicept and iNKT cells) plus standard of care, and a Control Arm receiving matching placebos plus standard of care. The study is double-blinded, meaning both participants and treating physicians are unaware of the assigned treatment to maintain objectivity. Blinding is maintained through the use of identical-appearing syringes for NAI/placebo and identical IV bags for iNKT cells/placebo.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Biological: Nogapendekin alfa inbakicept (NAI)Participants in this arm receive the investigational treatments: Nogapendekin Alfa Inbakicept (NAI) administered subcutaneously on Day 1 and Day 10, and iNKT cells administered intravenously on Day 3. All participants also receive standard of care (SOC) treatments for severe community-acquired pneumonia, with or without sepsis/ARDS. |
| Control Arm | Placebo comparator | Biological: agenT-797Participants in this arm receive placebos matching the investigational treatments: a subcutaneous placebo on Day 1 and Day 10, and an intravenous placebo on Day 3. All participants also receive standard of care (SOC) treatments for severe community-acquired pneumonia, with or without sepsis/ARDS. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥ 18 years, adult participants of any gender.
- Critically ill adults requiring admission to an ICU-unit due to severe community acquired pneumonia.
- Hospital admission with a diagnosis of CAP within 72 hours.
- Lymphopenia/ Absolute Lymphocyte Count (ALC): ALC < 1,500/μL (not secondary due to chemotherapy).
- Participants already treated by antibiotics (at least one dose since admission to the ICU).
Key exclusion criteria (16 listed)
- Hematologic malignancies (eg, active leukemia and lymphoma, not in remission).
- Post CAR-T cells therapy or hematopoietic cell transplant for ALL, NHL or Multiple Myeloma less than 3 months prior to enrollment.
- Participant diagnosed with cytokine release syndrome.
- Participant receiving colony stimulating factors eg, G-CSF.
- Clinical history or radiological imaging suggesting aspiration of gastric content.
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)NAI is a soluble complex consisting of two protein subunits of a human IL-15 variant (nogapendekin alfa) bound with high affinity to a dimeric human IL 15Rα sushi domain/human IgG1 Fc fusion protein (inbakicept). | Biological | Experimental Arm |
| agenT-797Allogeneic invariant NKT (iNKT) cell therapy - an off-the-shelf cell therapy that can rapidly orchestrate both innate and adaptive immunity. | Biological | Control Arm |
Primary outcome
28-day all-cause mortality
Time frame: 30 days after the last dose of study drug
Up to Day 28 from randomization. (Participants lost to follow-up before Day 28 will be censored at their last known date alive; participants alive on Day 28 will be censored at Day 28).
9 secondary outcomes
ALC count
Time frame: From randomization through 28 days following randomization.
Ventilator-Free days (VFD) through Day 28.
Time frame: Through 28 days following randomization.
Number of ICU free days through Day 28.
Time frame: Through 28 days following randomization.
Number of antibiotic free days through Day 28.
Time frame: Through 28 days following randomization.
Number of days alive and free of organ support through 28 days.
Time frame: Through 28 days following randomization.
Time from first administration of study drug to ICU discharge.
Time frame: From first study drug administration until ICU discharge, assessed up to 90 days; ICU discharge date documented from medical record (participants not discharged by Day 90 censored at Day 90; deaths prior to discharge counted as competing events).
Time from first administration of study drug to hospital discharge.
Time frame: From first study drug administration until hospital discharge, assessed up to 90 days; hospital discharge date documented from medical record (participants not discharged by Day 90 censored at Day 90; deaths prior to discharge counted as competing events
Incidence of secondary infections through Day 28 and for the entire study.
Time frame: From randomization through 90 days following randomization.
90-day all-cause mortality.
Time frame: Through 90 days following randomization.
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.
Jayson Garmizo study director
ImmunityBio, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nogapendekin alfa inbakicept (NAI) and agenT-797 in people with Community-Acquired Pneumonia (CAP) and Acute Respiratory Distress Syndrome (ARDS), run by ImmunityBio, Inc..
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 19 inclusion and 16 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: 30 days after the last dose of study drug). 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 8 May 2026.