EBNK-001 allogeneic NK cell therapy with low-dose IL-15, with or without pembrolizumab, for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

EBNK-001 is an off-the-shelf allogeneic natural killer (NK) cell product given after a short course of lymphodepleting cyclophosphamide and fludarabine to help the cells expand and persist. Participants receive weekly NK-cell infusions for three consecutive weeks per cycle (for example, Days 1, 8, 15) with low-dose IL-15 given after infusions to support NK-cell survival; some arms add pembrolizumab. The Phase 1 portion uses dose escalation to identify a recommended Phase 2 dose (RP2D) and monitors dose-limiting toxicities in the first 28 days, while Phase 2 tests preliminary efficacy at the RP2D in selected tumor cohorts using RECIST-based response criteria. Participants are followed for tumor response until progression and for survival for at least 12 months, with possible long-term follow-up if the product is considered gene-modified.

Why it matters

Who can join: the full rules

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.

Where it's running

• District One Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Rhoda M Smith, Phd
• Email: clinical-trials@essen-biotech.com
• Phone: 2077706670

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.