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Clinical Trials in China / NCT07410676
Recruiting Phase 1/2

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

NCT07410676 · tracked via the Priya Life Science China tracker
Sponsor
Essen Biotech
Phase
Phase 1/2
Started
2026-02-01
Last updated
2026-02-18

Condition(s) studied

CancerSarcomaLeukaemiaBreast 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

Investigational drug(s) / intervention(s)

EBNK-001 + IL-15 + Pembrolizumab →

EBNK-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

Study 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

Sex
ALL
Min age
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
District One Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07410676 on ClinicalTrials.gov ↗ ← All trials in China