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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06239220 | PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC | PHASE2 | RECRUITING | 25 | — | — | Feb 16, 2024 | Jan 31, 2027 | Feb 27, 2026 | 2 | United States |
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECISTv1.1 criteria.
| Arm | Type | Description |
|---|---|---|
| Dose Level 0: PD-L1 t-haNK + NAI + Cetuximab | EXPERIMENTAL | Dose level modifications of PD-L1 t-haNK and NAI due to toxicities will follow protocol specifications, starting at Dose Level 0 and de-escalating to Dose Level -1. Participants will complete: * Baseline visit. * Imaging scans every 8 weeks while on study. * Cycle 1 through End of Treatment: --Days 1 and 15 of 28 day cycle in the following order: Predetermined dose of PD-L1 t-haNK 1x daily, predetermined dose of NAI 1x daily, and predetermined dose of Cetuximab 1x daily. * End of Treatment visit with assessments. * Follow up: follow up every 3-4 months for up to 3 years after end of treatment. Longer-term follow-up every 6-12 months for up to 15 years. |
| Dose Level -1: PD-L1 t-haNK + NAI + Cetuximab | EXPERIMENTAL | Dose level modifications of PD-L1 t-haNK and NAI due to toxicities will follow protocol specifications. Participants will complete: * Baseline visit. * Imaging scans every 8 weeks while on study. * Cycle 1 through End of Treatment: --Days 1 and 15 of 28 day cycle in the following order: Predetermined dose of PD-L1 t-haNK 1x daily, predetermined dose of NAI 1x daily, and predetermined dose of Cetuximab 1x daily. * End of Treatment visit with assessments. * Follow up: follow up every 3-4 months for up to 3 years after end of treatment. Longer-term follow-up every 6-12 months for up to 15 years. |
| Name | Type | Description |
|---|---|---|
| PD-L1 t-haNK | BIOLOGICAL | Allogeneic, stable, clonal natural killer cell line product, via intravenous infusion (into the vein) per protocol. |
| Cetuximab | DRUG | Epidermal growth factor receptor, via intravenous (into the vein) infusion per institutional standard of care. |
| NAI | BIOLOGICAL | Recombinant human superagonist, via subcutaneous injection (under the skin) per protocol. |
Inclusion Criteria: * Participants must have an existing histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) with evidence of recurrent, metastatic (R/M) or locoregionally advanced, incurable or unresectable disease from any mucosal subsite including oral cavity, oro...