Actively Recruiting

Phase 1
Phase 2
All Genders
NCT07410676

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

Led by Essen Biotech · Updated on 2026-02-18

83

Participants Needed

1

Research Sites

202 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

District One Hospital

Beijing, Beijing Municipality, China, 086-373

Actively Recruiting

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Research Team

R

Rhoda M Smith, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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