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Recruiting NCT07410676

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

Phase I / Phase II Interventional Cancer Sarcoma Leukaemia Breast Cancer (Locally Advanced or Metastatic)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EBNK-001 + IL-15 + Pembrolizumab.
Who it may be relevant to
Registry conditions: Cancer, Sarcoma, Leukaemia, Breast Cancer (Locally Advanced or Metastatic). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Detailed description

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.

Interventions

  • Biological EBNK-001 + IL-15 + Pembrolizumab
    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 Dru

Primary outcome measures

  • Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [Time frame: 30 DAYS]
  • Incidence of Dose-Limiting Toxicities (DLTs) [Time frame: 30 DAYS]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • District One Hospital — Beijing

Identifiers

NCT: NCT07410676 · EB-NK-ST-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗