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Recruiting Phase 1 / Phase 2

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

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About this study

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.

Condition
Cancer, Sarcoma, Leukaemia, Breast Cancer (Locally Advanced or Metastatic), Lung Cancer (Diagnosis), Colorectal Cancer, Melanoma (Skin Cancer), Bladder Cancer, Kidney Cancer, Pancreatic Cancer Metastatic, Liver Cancer (Primary and Metastatic), Ovarian Cancer, Esophageal Cancer, Glioblastoma, Non-Melanoma Skin Cancer
Tested
EBNK-001 + IL-15 + Pembrolizumab
Sponsor
Essen Biotech

Who can join

Age
Not specified
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 12

  • Study condition: Cancer, Sarcoma, Leukaemia, Breast Cancer (Locally Advanced or Metastatic), Lung Cancer (Diagnosis), Colorectal Cancer, Melanoma (Skin Cancer), Bladder Cancer, Kidney Cancer, Pancreatic Cancer Metastatic, Liver Cancer (Primary and Metastatic), Ovarian Cancer, Esophageal Cancer, Glioblastoma, Non-Melanoma Skin Cancer
  • 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 9

  • 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

1 site, 1 recruiting

District One Hospital

Beijing, Beijing Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.