Donor natural killer cells with IL-15, with or without pembrolizumab, in advanced solid tumors
Tests EBNK-001 donor immune cells with IL-15 in adults with advanced solid tumors.
Plain-language title generated from the registry record
Registry title: EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1/2
Where in China
- District One HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Essen Biotech
- Trial code
- NCT07410676
- Record updated
- 18 February 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age ≥18 years; Histologically confirmed advanced/metastatic solid tumor that is relapsed/refractory after standard therapy (or no standard therapy available); Measurable disease per RECIST v1.1 (or iRECIST if applicable); ECOG performance status 0-1 (or 0-2 as allowed); Adequate organ function (thresholds modeled on NK protocols):; Platelets ≥ 75,000/µL; hemoglobin ≥ 9 g/dL; ANC ≥ 1,000/µL (unsupported by growth factors/transfusions as defined); eGFR ≥ 60 mL/min/1.73m²; AST/ALT ≤ 3× ULN; Oxygen saturation ≥ 90% on room air (with PFT requirements if indicated); LVEF ≥ 40% (by ECHO/MUGA/CMR); If brain metastases are present, they must be stable for a defined period (example: ≥3 months) and not requiring escalating steroids.
Exclusion: Receipt of investigational agent within 28 days before first study drug; Live vaccine within 6 weeks prior to lymphodepletion; Any condition requiring systemic immunosuppression (e.g., >5 mg prednisone/day or equivalent) during dosing window (topical/inhaled may be allowed); Active autoimmune disease requiring systemic immunosuppression; Uncontrolled bacterial, fungal, or viral infection; Known HIV positivity or active hepatitis B/C with detectable viral load (protocol may allow chronic asymptomatic hepatitis depending on risk plan); Any medical/social condition likely to interfere with study compliance or increase risk; Known allergy to investigational product components (example: albumin/human or DMSO); Pregnant or breastfeeding.