MedTrace Logo

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

NCT07492888 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-05-08

No results posted yet for this study

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. The study will give NAI by subcutaneous injection (Days 1 and 10) and one IV dose of iNKT cells (Day 3), then follow participants for 90 days.

Conditions

  • Acute Respiratory Distress Syndrome
  • Severe Community-Acquired Pneum
  • Sepsis
  • Lymphopenia / Immunoparalysis in Critically Ill Adults

Interventions

DRUG

Nogapendekin Alfa-Inbakicept (NAI)

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.

DRUG

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.

Sponsors & Collaborators

  • ImmunityBio, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2026-11-15
Completion
2027-01-15
FDA Drug
Yes

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07492888 on ClinicalTrials.gov