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

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.

Interventions

• 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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (1)

• District One Hospital, Beijing, Beijing Municipality · Recruiting