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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic solid tumors that came back or stopped responding after standard treatment. They get NK cell therapy with low-dose IL-15, with or without pembrolizumab.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Advanced or metastatic solid tumor, confirmed by tissue examination, that relapsed or did not respond to standard therapy (or no standard therapy is available). The disease must be measurable by RECIST v1.1 (or iRECIST if applicable). If brain metastases are present, they must be stable (example: for 3 months or more) and not need rising steroid doses.
- Earlier treatment
- Relapsed or refractory after standard therapy, or no standard therapy available. No investigational agent within 28 days before the first study drug. No live vaccine within 6 weeks before lymphodepletion.
Main reasons for not taking part
- Pregnant or breastfeeding
- Needs systemic immunosuppression (for example more than 5 mg prednisone a day) or has active autoimmune disease needing it
- Uncontrolled bacterial, fungal or viral infection
- Known HIV positivity or active hepatitis B/C with detectable viral load
- Known allergy to components of the study product (example: albumin/human or DMSO)
Read by machine on 9 November 2026.
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.