Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (15)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer (Locally Advanced or Metastatic) | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Leukaemia | Leukemia | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EBNK-001 + IL-15 + Pembrolizumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EBNK-001 + IL-15 + Pembrolizumab
- interventionNames
- Biological: EBNK-001 + IL-15 + Pembrolizumab
Primary outcomes (2)
- measure
- Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
- timeFrame
- 30 DAYS
- measure
- Incidence of Dose-Limiting Toxicities (DLTs)
- timeFrame
- 30 DAYS
- description
- Incidence of Dose-Limiting Toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available