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NCT Number: NCT07410676

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

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.

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Key information

Conditions

Cancer Adnexal Diseases Astrocytoma Bladder Cancer Breast Cancer (Locally Advanced or Metastatic) Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Glioblastoma Glioma Gonadal Disorders Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Intestinal Diseases Intestinal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Leukaemia Leukemia Liver Cancer (Primary and Metastatic) Liver Diseases Liver Neoplasms Lung Cancer (Diagnosis) Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Melanoma (Skin Cancer) Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-Melanoma Skin Cancer Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Metastatic Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

District One Hospital

Beijing, Beijing Municipality, 086-373, China

Location status: Recruiting

Location contact

SAMI XI, dr

CONTACT

[email protected]

+14012275001

About this study

EBNK-001 is an "off-the-shelf" allogeneic NK cell product intended for multi-dose administration. Participants first receive a short course of lymphodepleting chemotherapy (CY/FLU) to facilitate NK-cell expansion and persistence, followed by weekly NK-cell infusions for 3 consecutive weeks in each treatment cycle (e.g., Days 1, 8, 15). Low-dose IL-15 is administered after NK-cell infusion(s) to support NK-cell survival.

The trial includes:

Phase 1 (Dose Escalation): evaluates escalating doses of EBNK-001 to identify MTD/RP2D based on DLTs observed in the first 28 days after first NK-cell infusion (DLT window).

Phase 2 (Dose Expansion): evaluates preliminary efficacy at RP2D in selected solid tumor expansion cohorts.

Participants are followed for tumor response until progression and for survival for at least 12 months. If EBNK-001 is considered a gene-modified cell product in your program, participants may transition into a separate long-term follow-up study consistent with long-term monitoring described in NK cell therapy protocols.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EBNK-001 + IL-15 + Pembrolizumab

Biological

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

Other names: Pembrolizumab, IL-15, EBNK-001

Primary outcomes

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

    Time frame: 30 DAYS

  2. Incidence of Dose-Limiting Toxicities (DLTs)

    Time frame: 30 DAYS

    Incidence of Dose-Limiting Toxicities (DLTs)

Study contacts

Contact information is provided by the study sponsor or research team.

Rhoda M Smith, Phd

CONTACT

[email protected]

2077706670

Sponsors and collaborators

Lead sponsor

Essen Biotech

Other

Registry information

Official study title

An Open-Label Phase 1/2 Study of EBNK-001, an Allogeneic Natural Killer (NK) Cell Therapy Administered After Cyclophosphamide/Fludarabine Lymphodepletion With Low-Dose Interleukin-15, With or Without Pembrolizumab, in Participants With Advanced Solid Tumors

Acronym: EBNK-ST-001

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 13, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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