RecruitingPhase 1Phase 2NCT07410676

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


Sponsor

Essen Biotech

Enrollment

83 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study tests EBNK-001, an engineered immune cell therapy using natural killer (NK) cells combined with a low dose of IL-15 (a protein that supports immune cell activity), with or without the immunotherapy drug pembrolizumab, in adults with advanced solid tumor cancers that have stopped responding to standard treatments. **You may be eligible if...** - You are 18 or older - You have a confirmed advanced or metastatic solid tumor that has relapsed or is no longer responding to standard therapy, or there is no standard treatment available - Your cancer can be measured on imaging scans - Your overall health is good (ECOG 0-2) - Your blood counts and major organ function are within acceptable limits **You may NOT be eligible if...** - You have an active uncontrolled infection - You have active autoimmune disease requiring systemic immune-suppressing medications - You are known HIV positive or have active hepatitis B or C with detectable viral levels - You are pregnant or breastfeeding - You have received another investigational drug within 28 days before treatment start - You received a live vaccine within 6 weeks before starting lymphodepletion (a preparatory step for the cell therapy) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEBNK-001 + IL-15 + Pembrolizumab

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


Locations(1)

District One Hospital

Beijing, Beijing Municipality, China

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NCT07410676


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