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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18 years. - diagnosed by tissue sample (biopsy-confirmed) advanced/metastatic solid tumor that is relapsed/refractory after standard therapy (or no standard therapy available). - tumors that can be measured on scans v1.1 (or iRECIST if applicable). - You should be able to carry out daily activities with 0 level of ability (ECOG 0)-1 (or 0-2 as allowed). - your organs (liver, kidneys, etc.) are working well enough based on blood tests (thresholds modeled on NK protocols): - platelet count at least 75,000/µL; blood count (hemoglobin) at least 9 g/dL; white blood cell count (ANC) at least 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. Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body) 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

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

Locations (1)

District One Hospital
Beijing, Beijing Municipality, China