NCT07410676RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 83 (estimated)
- First submitted
- 7 Feb 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 21 Dec 2028
- Lead sponsor
- Essen Biotech
- Diseases
- Prostate cancer, Melanoma, Bladder cancer, Kidney cancer, Sarcoma, Glioblastoma, Lung cancer, Pancreatic cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer, Childhood cancers
- NCT number
- NCT07410676
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 83
- From 1 Feb 2026 to the primary completion date, 21 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of investigational agent within 28 days before first study drug.
- Live vaccine within 6 weeks prior to lymphodepletion.
Other illness
- 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.
Lab values
- Known allergy to investigational product components (example: albumin/human or DMSO).
Other
- Pregnant or breastfeeding.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| District One Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.