NCT07410676

EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors

An Open-Label Phase 1/2 Study of EBNK-001, an Allogeneic Natural Killer (NK) Cell Therapy Administered After Cyclophosphamide/Fludarabine Lymphodepletion With Low-Dose Interleukin-15, With or Without Pembrolizumab, in Participants With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 83 (estimated)
• Sponsor: Essen Biotech · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of EBNK-001 (allogeneic NK cells) given after lymphodepleting cyclophosphamide/fludarabine (CY/FLU) and supported with low-dose IL-15, administered either alone or in combination with pembrolizumab in adults with advanced/metastatic solid tumors. The study will determine a recommended Phase 2 dose (RP2D) and explore signals of clinical activity using RECIST-based response criteria.

Detailed description

EBNK-001 is an "off-the-shelf" allogeneic NK cell product intended for multi-dose administration. Participants first receive a short course of lymphodepleting chemotherapy (CY/FLU) to facilitate NK-cell expansion and persistence, followed by weekly NK-cell infusions for 3 consecutive weeks in each treatment cycle (e.g., Days 1, 8, 15). Low-dose IL-15 is administered after NK-cell infusion(s) to support NK-cell survival. The trial includes: Phase 1 (Dose Escalation): evaluates escalating doses of EBNK-001 to identify MTD/RP2D based on DLTs observed in the first 28 days after first NK-cell infusion (DLT window). Phase 2 (Dose Expansion): evaluates preliminary efficacy at RP2D in selected solid tumor expansion cohorts. Participants are followed for tumor response until progression and for survival for at least 12 months. If EBNK-001 is considered a gene-modified cell product in your program, participants may transition into a separate long-term follow-up study consistent with long-term monitoring described in NK cell therapy protocols.

Conditions

• Cancer
• Sarcoma
• Leukaemia
• Breast Cancer (Locally Advanced or Metastatic)
• Lung Cancer (Diagnosis)
• Colorectal Cancer
• Melanoma (Skin Cancer)
• Bladder Cancer
• Kidney Cancer
• Pancreatic Cancer Metastatic
• Liver Cancer (Primary and Metastatic)
• Ovarian Cancer
• Esophageal Cancer
• Glioblastoma
• Non-Melanoma Skin Cancer

Interventions

Type	Name	Description
BIOLOGICAL	EBNK-001 + IL-15 + Pembrolizumab	Biological: EBNK-001 (Allogeneic NK Cells) Dose levels (example): 1×10\^8; 3×10\^8; 9×10\^8 viable cells/infusion Schedule: weekly infusions on Days 1, 8, and 15 (per cycle) Drug: Cyclophosphamide (CY) lymphodepletion: 300 mg/m² IV daily ×2 days (Cycle 1 only) Drug: Fludarabine (FLU) Example lymphodepletion: 25 mg/m² IV daily ×2 days (Cycle 1 only) Drug: Interleukin-15 (IL-15) Low-dose IL-15 given after NK cell infusion to support NK cell survival dose used in NK protocols: 6 MIU per dose Drug: Pembrolizumab Pembrolizumab administered per standard prescribing schedule

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-12-21
• Completion: 2029-12-21
• First posted: 2026-02-13
• Last updated: 2026-02-18

Locations

1 site across 1 country: China