Actively Recruiting
An Open-Label Phase 1/2 Study of EBNK-001, an Allogeneic Natural Killer (NK) Cell Therapy After Cyclophosphamide/Fludarabine Lymphodepletion With Low-Dose Interleukin-15, With or Without Pembrolizumab, in Advanced Solid Tumors
Led by Essen Biotech · Updated on 2026-02-18
83
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and early anti-tumor effects of EBNK-001, an off-the-shelf allogeneic natural killer (NK) cell therapy, given with low-dose interleukin-15. This Phase 1/2 study includes adults with advanced or metastatic solid tumors that have returned or not responded to standard treatments. The trial aims to find the best dose for further study and assess tumor responses using established criteria. Participants first receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine to help the NK cells expand and last longer. Then, they get weekly infusions of EBNK-001 on Days 1, 8, and 15 of each treatment cycle, supported by low-dose IL-15 after each infusion. The study has two parts: Phase 1 tests increasing doses to identify the maximum tolerated dose and recommended dose for Phase 2, while Phase 2 focuses on preliminary effectiveness in selected tumor types. Some participants may also receive pembrolizumab alongside the NK cell therapy. During the study, participants are monitored for tumor response until their disease progresses and followed for survival for at least 12 months. Researchers track side effects and serious adverse events closely, especially in the first 30 days after the first NK cell infusion. If EBNK-001 is considered gene-modified, participants might join a long-term follow-up study to monitor safety. The overall participation duration depends on individual response and treatment continuation.
CONDITIONS
Brief Title
EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed advanced or metastatic solid tumor that is relapsed or refractory after standard therapy or has no standard therapy available
- Measurable disease according to RECIST v1.1 or iRECIST
- ECOG performance status of 0-1 or 0-2 as allowed
- Adequate organ function including platelets ≥ 75,000/µL, hemoglobin ≥ 9 g/dL, ANC ≥ 1,000/µL without growth factors or transfusions
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m²
- AST and ALT levels ≤ 3 times the upper limit of normal
- Oxygen saturation ≥ 90% on room air
- Left ventricular ejection fraction (LVEF) ≥ 40% by heart function tests
- If brain metastases are present, they must be stable for at least 3 months and not require increasing steroids
You will not qualify if you...
- Pregnant or breastfeeding
- Conditions requiring systemic immunosuppression greater than 5 mg prednisone daily or equivalent during dosing (topical or inhaled allowed)
- Active autoimmune disease needing systemic immunosuppression
- Uncontrolled bacterial, fungal, or viral infections
- 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 or C with detectable viral load
- Known allergy to components of the investigational product such as albumin or DMSO
- Any medical or 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive a short course of lymphodepleting chemotherapy followed by weekly infusions of EBNK-001 natural killer cells and low-dose IL-15 for 3 consecutive weeks in each treatment cycle. Pembrolizumab may also be administered per standard schedule.
Weekly visits for NK-cell infusions on Days 1, 8, and 15 of each cycle
Duration - At least 12 months
Participants are followed for tumor response until progression and for survival for at least 12 months after treatment ends.
Visits scheduled periodically for tumor response and survival assessments
Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, Phd
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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