Immune boosting study for severe pneumonia pulled before start
NCT ID NCT07492888
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study was designed to see if adding two immune treatments (NAI and iNKT cells) to standard care could help critically ill adults with severe pneumonia, sepsis, or lung failure recover. It planned to enroll ICU patients and follow them for 90 days. However, the study was withdrawn before any participants were enrolled, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 105 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria- 1. Age ≥ 18 years. 2. 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. 3. Hospital admission with diagnosis of CAP within 72 hours. 4. Lymphopenia: absolute lymphocyte count (ALC) \< 1,500/µL (not secondary to chemotherapy). 5. Receiving antibiotics for CAP (at least one dose since ICU admission). 6. Informed consent obtainable from participant or legally authorized representative. Exclusion Criteria- 1. Hematologic malignancy (e.g., active leukemia or lymphoma not in remission). 2. Post CAR T therapy or hematopoietic cell transplant for ALL, NHL, or multiple myeloma \< 3 months prior to enrollment. 3. Current diagnosis of cytokine release syndrome. 4. Receiving colony stimulating factors (e.g., G CSF). 5. Clinical history or imaging suggesting aspiration of gastric contents. 6. Advanced dementia or prolonged bedridden status. 7. Pregnancy or breastfeeding. 8. 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.) 9. Uncontrolled autoimmune or inflammatory disease requiring immunosuppressive therapies. 10. Life expectancy \< 24-48 hours or moribund condition despite care (investigator judgment). 11. Active uncontrolled bleeding or intracerebral hemorrhage. 12. Known hypersensitivity to ingredients used in the cell product formulation (e.g., DMSO). 13. 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). 14. Known active viral hepatitis A, B, or C. 15. Investigator judgment that participation is not in the participant's best interest or participant is unsuitable for enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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