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

ConditionsCancer 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

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

EBNK-001 + IL-15 + Pembrolizumab
Biological/Vaccine
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

Treatment groups

83 Participants

are divided into 1 treatment group

Group A: EBNK-001 + IL-15 + PembrolizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Time frame

30 DAYS

Incidence of Dose-Limiting Toxicities (DLTs)

Time frame

30 DAYS

Sponsors and contacts

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Essen Biotech

Lead sponsor

Source ClinicalTrials.gov

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