Health Trials

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

ConditionsCancerSarcomaLeukaemiaBreast Cancer (Locally Advanced or Metastatic)Lung Cancer (Diagnosis)Colorectal CancerMelanoma (Skin Cancer)Bladder CancerKidney CancerPancreatic Cancer MetastaticLiver Cancer (Primary and Metastatic)Ovarian CancerEsophageal CancerGlioblastomaNon-Melanoma Skin Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEssen Biotech

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • EBNK-001 + IL-15 + Pembrolizumab

Treatment groups

83 Participants
are divided into 1 treatment group

Sponsors and collaborators

Essen Biotech

Lead sponsor

Source ClinicalTrials.gov