EBNK-001 allogeneic NK cell therapy with low-dose IL-15, with or without pembrolizumab, for advanced solid tumors

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

This treatment tests an off-the-shelf NK cell product (EBNK-001) given with low-dose IL-15, either alone or with pembrolizumab, in adults with advanced or metastatic solid tumors who have exhausted standard options.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 83 (estimated)
• Sex: All
• Sponsor: Essen Biotech (Academic / other)
• Drugs / interventions: prednisone, pembrolizumab, cyclophosphamide, fludarabine, chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07410676 on ClinicalTrials.gov

What this trial studies

EBNK-001 is an off-the-shelf allogeneic natural killer (NK) cell product given after a short course of lymphodepleting cyclophosphamide and fludarabine to help the cells expand and persist. Participants receive weekly NK-cell infusions for three consecutive weeks per cycle (for example, Days 1, 8, 15) with low-dose IL-15 given after infusions to support NK-cell survival; some arms add pembrolizumab. The Phase 1 portion uses dose escalation to identify a recommended Phase 2 dose (RP2D) and monitors dose-limiting toxicities in the first 28 days, while Phase 2 tests preliminary efficacy at the RP2D in selected tumor cohorts using RECIST-based response criteria. Participants are followed for tumor response until progression and for survival for at least 12 months, with possible long-term follow-up if the product is considered gene-modified.

Who should consider this trial

Good fit: Adults (≥18) with measurable relapsed or refractory advanced/metastatic solid tumors, ECOG performance status typically 0–1 (or up to 0–2 as allowed), and adequate organ function who can tolerate lymphodepletion are the intended candidates.

Not a fit: Patients who are pregnant or breastfeeding, require systemic immunosuppression, have uncontrolled infection, poor organ function, or unstable brain metastases are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, this approach could produce tumor shrinkage or longer disease control in patients with advanced solid tumors who have limited standard treatment options.

How similar studies have performed: Early-phase studies of allogeneic NK-cell therapies and IL-15 support have shown acceptable safety and occasional tumor responses, but larger confirmatory data are still limited and combination approaches with checkpoint inhibitors remain exploratory.

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.

Where this trial is running

Beijing, Beijing Municipality

• District One Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Rhoda M Smith, Phd

Conditions Cancer; Sarcoma; Leukaemia; Breast Cancer; Lung Cancer; Colorectal Cancer; Melanoma; Bladder Cancer