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

Recruiting now · Phase 1/Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT07410676

Run by

Essen Biotech

People needed

83

Starts

2026-02-01

Expected to finish

2029-12-21

Last updated by the study team

2026-02-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pregnant or breastfeeding.
• 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.
• Receipt of investigational agent within 28 days before first study drug.
• Live vaccine within 6 weeks prior to lymphodepletion.
• Known HIV positivity or active hepatitis B/C with detectable viral load (protocol may allow chronic asymptomatic hepatitis depending on risk plan).
• Known allergy to investigational product components (example: albumin/human or DMSO).
• Any medical/social condition likely to interfere with study compliance or increase risk.

Where it is running

• District One Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.