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NAI for Sepsis With Persistent Lymphopenia

ConditionsSepsisSeptic ShockLymphopeniaImmunosuppressionCritical Illness
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunityBio, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older at the time of informed consent

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

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)

Prior initiation of appropriate antimicrobial therapy per institutional guidelines

Disqualifiers

Hematologic malignancies including leukemia, lymphoma, and myelodysplastic syndromes

Prior CAR-T cell therapy or hematopoietic stem cell transplant (HSCT) within 3 months of screening

Active cytokine release syndrome (CRS) at screening

Current or recent (within 7 days) use of colony stimulating factors (G-CSF, GM-CSF)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nogapendekin alfa inbakicept (NAI)

    Drug

    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

  • Standard of Care (SOC)

    Other intervention

    Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, organ support, and mechanical ventilation as clinically indicated

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: NAI + Standard of CareExperimental treatment 2 interventions
Group B: Standard of Care AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

28-day all-cause mortality rate

Proportion of participants who die from any cause within 28 days of randomization

Time frame
28 days

Secondary outcomes

1

Change in absolute lymphocyte count (ALC)

Change in ALC from baseline (Day 1 pre-dose) through Day 28

Time frame
Baseline through Day 28
2

ICU re-admission rate

Proportion of participants re-admitted to ICU after discharge by Day 90

Time frame
Up to Day 90
3

Secondary infections

Proportion of participants with secondary infections after discharge by Day 90

Time frame
Up to Day 90
4

90-day all-cause mortality rate

Proportion of participants who die from any cause within 90 days of randomization

Time frame
90 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ImmunityBio, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: