Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07578558 | NAI for Sepsis With Persistent Lymphopenia | PHASE2 | NOT YET_RECRUITING | 50 | — | — | Jul 6, 2026 | Oct 4, 2027 | May 11, 2026 | - | — |
Proportion of participants who die from any cause within 28 days of randomization
| Arm | Type | Description |
|---|---|---|
| NAI + Standard of Care | EXPERIMENTAL | 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 |
| Standard of Care Alone | ACTIVE_COMPARATOR | Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, and mechanical ventilation as clinically indicated |
| Name | Type | Description |
|---|---|---|
| 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 | Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, organ support, and mechanical ventilation as clinically indicated |
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 Asses...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| ImmunityBio Inc | IBRX | 1 | PHASE2 | Nogapendekin alfa inbakicept |
| Bluejay Diagnostics, Inc. | BJDX | 2 | — | Undisclosed |
| CytoSorbents Corporation | CTSO | 1 | — | Undisclosed |
| Danaher Corporation | DHR | 3 | — | Undisclosed |
| Spectral AI, Inc. Class A | MDAI | 1 | NA | Undisclosed |