Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Communi… (NCT07492875) | Clinical Trial Compass
WithdrawnPhase 3
Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia
Stopped: New protocol developed
0Started 2026-04-15
Plain-language 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.
Who can participate
Age range18 Years – 105 Years
SexALL
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Inclusion criteria
✓. 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).
✓. 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).
Exclusion criteria
✕. 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.
✕. 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.