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

Sponsor: Essen Biotech · NCT07410676 on ClinicalTrials.gov ↗

Conditions studied

CancerSarcomaLeukaemiaBreast Cancer (Locally Advanced or Metastatic)Lung Cancer (Diagnosis)Colorectal CancerMelanoma (Skin Cancer)Bladder CancerKidney CancerPancreatic Cancer MetastaticLiver Cancer (Primary and Metastatic)Ovarian CancerEsophageal CancerGlioblastomaNon-Melanoma Skin Cancer

What it tests

  • EBNK-001 + IL-15 + Pembrolizumabbiological

Where it's running1 site

1 international site
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

Inclusion Criteria:

* 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 Criteria:

* 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.

Updated 2026-02-18 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.