Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia

NCT07492875 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: ResQ218B-CAP
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

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); Immunotherapy; Immunomodulation; Lymphopenia; Critical Illness; Randomized Controlled Trial; Phase 3

Outcome Measures

Primary Outcomes (1)

• 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).

  30 days after the last dose of study drug

Secondary Outcomes (9)

• ALC count

  From randomization through 28 days following randomization.

• Ventilator-Free days (VFD) through Day 28.

  Through 28 days following randomization.

• Number of ICU free days through Day 28.

  Through 28 days following randomization.

• Number of antibiotic free days through Day 28.

  Through 28 days following randomization.

• Number of days alive and free of organ support through 28 days.

  Through 28 days following randomization.

Other Outcomes (9)

• Treatment Emergent Adverse Events (TEAEs).

  From first study drug administration through 30 days after the last study drug administration.

• Serious Adverse Events (SAEs).

  From first study drug administration through 30 days after the last study drug administration, with related SAEs followed until resolution or stabilization.

• Grade ≥3 TEAEs

  From first study drug administration through 30 days after the last study drug administration.

Study Arms (2)

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.

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.

Biological: agenT-797

Interventions

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).

Experimental Arm

agenT-797 BIOLOGICAL

Allogeneic invariant NKT (iNKT) cell therapy - an off-the-shelf cell therapy that can rapidly orchestrate both innate and adaptive immunity.

Control Arm

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• Pregnancy or breastfeeding.
• 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).

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

MeSH Terms

Conditions

Community-Acquired Pneumonia; Respiratory Distress Syndrome; Sepsis; Lymphopenia; Critical Illness

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes

Study Officials

• Jayson Garmizo

  ImmunityBio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a double-blind study, meaning that participants, treating physicians, and most study personnel and sponsor staff are unaware of which treatment (active drug or placebo) a participant receives. Blinding is maintained through the use of identical-looking active drugs and placebos.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: March 25, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 15, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 8, 2026

Record last verified: 2026-03