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NAI for Sepsis With Persistent Lymphopenia

5. maj 2026 opdateret af: ImmunityBio, Inc.

Phase 2, Randomized, Open-Label Clinical Trial Evaluating Nogapendekin Alfa Inbakicept in Combination With Standard of Care Versus Standard of Care Alone in Critically Ill Adults With Sepsis and Persistent Lymphopenia

This is a Phase 2, randomized, open-label study evaluating the safety and efficacy of nogapendekin alfa inbakicept (NAI, ANKTIVA®) in combination with standard of care versus standard of care alone in critically ill adults with sepsis and persistent lymphopenia. The study aims to determine whether NAI can improve 28-day mortality by addressing the immunosuppressive phase of sepsis characterized by persistent lymphopenia (absolute lymphocyte count <1,000 cells/µL). Participants will be randomized 1:1 to receive either NAI 1.2 mg subcutaneous injection on Days 3 (or earlier if ALC <700 cells/µL), Day 14, and potentially Day 21 if ALC remains <1,000 cells/µL, plus standard of care, or standard of care alone. The study will enroll approximately 50 participants (25 per arm) with persistent lymphopenia.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Sepsis is characterized by a biphasic immune response: an initial hyperinflammatory phase followed by a prolonged immunosuppressive phase with persistent lymphopenia. The majority of sepsis deaths (>70%) occur during the immunosuppressive phase rather than the initial hyperinflammatory phase. This acquired immunosuppression correlates with markedly increased 28-day mortality rates exceeding 40% and significantly elevated risk of secondary infections.

This study evaluates NAI, an IL-15 receptor agonist that promotes proliferation and activation of NK cells and CD8+ T cells, as a potential therapy to restore immune function in critically ill adults with sepsis and persistent lymphopenia (ALC <1,000 cells/µL on two consecutive measurements within 72 hours of sepsis diagnosis).

Study Arms:

  • Experimental Arm: NAI 1.2 mg subcutaneous injection administered on Days 3 (or earlier than Day 3 if ALC is <700 cells/µL), Day 14, and Day 21 if needed for ALC <1,000 cells/µL, plus institutional standard of care for sepsis
  • Control Arm: Institutional standard of care for sepsis alone Standard of care may include antimicrobial therapy, fluid resuscitation, vasopressor support, organ support, and mechanical ventilation as clinically indicated. Treatment will be discontinued if a participant has unacceptable toxicity, withdraws consent, or if the Investigator feels it is no longer in the participant's best interest to continue.

All participants will be followed for 90 days post the first dose of study treatment to capture late adverse events, rehospitalization, or mortality.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age 18 years or older at the time of informed consent
  2. Admitted to the ICU with a diagnosis of sepsis as defined by Sepsis-3 criteria: life-threatening organ dysfunction caused by a dysregulated host response to infection, operationalized as a Sequential Organ Failure Assessment (SOFA) score increase of 2 or more points
  3. Documented persistent lymphopenia defined as ALC <1,000 cells/µL on at least two consecutive measurements within 72 hours of sepsis diagnosis (measurements must be separated by at least 12 hours)
  4. Prior initiation of appropriate antimicrobial therapy per institutional guidelines
  5. Ability to obtain written informed consent from the participant or legally authorized representative
  6. Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males (for up to 7 months after completion of therapy)

Exclusion Criteria:

  1. Hematologic malignancies including leukemia, lymphoma, and myelodysplastic syndromes
  2. Prior CAR-T cell therapy or hematopoietic stem cell transplant (HSCT) within 3 months of screening
  3. Active cytokine release syndrome (CRS) at screening
  4. Current or recent (within 7 days) use of colony stimulating factors (G-CSF, GM-CSF)
  5. Lymphopenia attributable to chemotherapy, radiation therapy, or immunosuppressive medications administered within 30 days prior to screening
  6. High-dose immunosuppressive therapy (>0.5 mg/kg prednisone equivalent daily), excluding physiologic replacement and stress-dose hydrocortisone for septic shock
  7. Life expectancy less than 24 hours as assessed by the treating physician
  8. Active uncontrolled bleeding requiring >2 units of packed red blood cells in the preceding 24 hours
  9. Known HIV infection with CD4 count <350 cells/µL and detectable viral load
  10. Known active viral hepatitis (hepatitis B or C with detectable viral load)
  11. Advanced dementia or other conditions precluding meaningful participation
  12. Known hypersensitivity to any component of the investigational products
  13. Participation in another interventional trial with an investigational immunomodulatory agent within 30 days prior to screening
  14. Pregnant or breastfeeding

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: NAI + Standard of Care
NAI 1.2 mg subcutaneous injection administered on Days 3 (or earlier if ALC <700 cells/µL), Day 14, and Day 21 if needed for ALC <1,000 cells/µL, plus institutional standard of care for sepsis
Medicin: Nogapendekin alfa inbakicept (NAI)
IL-15 receptor agonist complex; 1.2 mg subcutaneous injection administered on Days 3 (or earlier if ALC <700 cells/µL), Day 14, and Day 21 if needed for ALC <1,000 cells/µL
Andre navne:
  • N-803
  • ANKTIVA
  • Nogapendekin alfa-inbakicept
Andet: Standard of Care (SOC)
Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, organ support, and mechanical ventilation as clinically indicated
Aktiv komparator: Standard of Care Alone
Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, and mechanical ventilation as clinically indicated
Andet: Standard of Care (SOC)
Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, organ support, and mechanical ventilation as clinically indicated

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
28-day all-cause mortality rate
Tidsramme: 28 days
Proportion of participants who die from any cause within 28 days of randomization
28 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in absolute lymphocyte count (ALC)
Tidsramme: Baseline through Day 28
Change in ALC from baseline (Day 1 pre-dose) through Day 28
Baseline through Day 28
ICU re-admission rate
Tidsramme: Up to Day 90
Proportion of participants re-admitted to ICU after discharge by Day 90
Up to Day 90
Secondary infections
Tidsramme: Up to Day 90
Proportion of participants with secondary infections after discharge by Day 90
Up to Day 90
90-day all-cause mortality rate
Tidsramme: 90 days
Proportion of participants who die from any cause within 90 days of randomization
90 days
Safety and tolerability
Tidsramme: Through Day 30 after last dose
Incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and Grade ≥3 TEAEs graded per NCI CTCAE v6.0
Through Day 30 after last dose

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ImmunityBio, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

6. juli 2026

Primær færdiggørelse (Anslået)

3. august 2027

Studieafslutning (Anslået)

4. oktober 2027

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

11. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ResQ2204-SEPSIS

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Sepsis

Kliniske forsøg med Nogapendekin alfa inbakicept (NAI)

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