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Immune boosting study for severe pneumonia pulled before start

NCT ID NCT07492888

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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 However, the study was withdrawn before any participants were enrolled, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

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

Anyone

Healthy volunteers

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

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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