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New treatment option for Cancer
Official title EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07410676
What this study is testing
What is EBNK-001 + IL-15 + Pembrolizumab?
EBNK-001 + IL-15 + Pembrolizumab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for cancer.
Also referred to as Pembrolizumab, IL-15.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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):
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.