NCT07410676

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P75+ for phase_1 cancer

Timeline
43mo left

Started Feb 2026

Typical duration for phase_1 cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Feb 2026Dec 2029

Study Start

First participant enrolled

February 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2029

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

2.9 years

First QC Date

February 7, 2026

Last Update Submit

February 14, 2026

Conditions

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

Keywords

Natural killer cellsNK cell therapySolid tumorsIL-15Breast CancerLung and Bronchus CancerProstate CancerColorectal (Colon and Rectal) CancerCAR-TNon-Melanoma Skin CancerMelanomaBladder CancerKidney (Renal Cell and Renal Pelvis) CancerPancreatic CancerStomach (Gastric) CancerEsophageal Cancer

Outcome Measures

Primary Outcomes (2)

  • Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    30 DAYS

  • Incidence of Dose-Limiting Toxicities (DLTs)

    Incidence of Dose-Limiting Toxicities (DLTs)

    30 DAYS

Study Arms (1)

EBNK-001 + IL-15 + Pembrolizumab

EXPERIMENTAL
Biological: EBNK-001 + IL-15 + Pembrolizumab

Interventions

EBNK-001 + IL-15 + PembrolizumabBIOLOGICAL

Biological: EBNK-001 (Allogeneic NK Cells) Dose levels (example): 1×10\^8; 3×10\^8; 9×10\^8 viable cells/infusion Schedule: weekly infusions on Days 1, 8, and 15 (per cycle) Drug: Cyclophosphamide (CY) lymphodepletion: 300 mg/m² IV daily ×2 days (Cycle 1 only) Drug: Fludarabine (FLU) Example lymphodepletion: 25 mg/m² IV daily ×2 days (Cycle 1 only) Drug: Interleukin-15 (IL-15) Low-dose IL-15 given after NK cell infusion to support NK cell survival dose used in NK protocols: 6 MIU per dose Drug: Pembrolizumab Pembrolizumab administered per standard prescribing schedule

Also known as: Pembrolizumab, IL-15, EBNK-001
EBNK-001 + IL-15 + Pembrolizumab

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District One Hospital

Beijing, Beijing Municipality, 086-373, China

RECRUITING

MeSH Terms

Conditions

NeoplasmsSarcomaLeukemiaBreast NeoplasmsNeoplasm MetastasisLung NeoplasmsDiseaseColorectal NeoplasmsMelanomaUrinary Bladder NeoplasmsKidney NeoplasmsLiver NeoplasmsOvarian NeoplasmsEsophageal NeoplasmsGlioblastomaCarcinoma, BronchogenicProstatic NeoplasmsPancreatic NeoplasmsStomach Neoplasms

Interventions

Interleukin-15pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesKidney DiseasesLiver DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersHead and Neck NeoplasmsEsophageal DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeoplasms, Glandular and EpithelialBronchial NeoplasmsGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesPancreatic DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Central Study Contacts

Rhoda M Smith, Phd

CONTACT

2077706670clinical-trials@essen-biotech.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Phase 1 dose-escalation to determine MTD/RP2D using DLT monitoring in an initial safety window (commonly \~28 days). Phase 2 expansion cohorts at RP2D to estimate preliminary efficacy in selected solid tumor types.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 13, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 21, 2028

Study Completion (Estimated)

December 21, 2029

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)