CancerPhase 1/2EBNK-ST-001NCT07410676
EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors
A Phase 1/2 study testing EBNK-001 + IL-15 + Pembrolizumab in people with Cancer and Sarcoma, run by Essen Biotech at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- What is being tested?
- EBNK-001 + IL-15 + Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 21 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
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- 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 cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
District One Hospital
Beijing, Beijing Municipality, 086-373
SAMI XI, dr, +14012275001, SFM@districtonehospital.com
About this study
Official title: 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
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.
Read the detailed description
EBNK-001 is an "off-the-shelf" allogeneic NK cell product intended for multi-dose administration. Participants first receive a short course of lymphodepleting chemotherapy (CY/FLU) to facilitate NK-cell expansion and persistence, followed by weekly NK-cell infusions for 3 consecutive weeks in each treatment cycle (e.g., Days 1, 8, 15). Low-dose IL-15 is administered after NK-cell infusion(s) to support NK-cell survival.
The trial includes:
Phase 1 (Dose Escalation): evaluates escalating doses of EBNK-001 to identify MTD/RP2D based on DLTs observed in the first 28 days after first NK-cell infusion (DLT window).
Phase 2 (Dose Expansion): evaluates preliminary efficacy at RP2D in selected solid tumor expansion cohorts.
Participants are followed for tumor response until progression and for survival for at least 12 months. If EBNK-001 is considered a gene-modified cell product in your program, participants may transition into a separate long-term follow-up study consistent with long-term monitoring described in NK cell therapy protocols.
- Conditions
- Cancer, Sarcoma, Leukaemia, Breast Cancer (Locally Advanced or Metastatic), Lung Cancer (Diagnosis), Colorectal Cancer
- Being tested
- EBNK-001 + IL-15 + Pembrolizumab
- Keywords
- Natural killer cells, NK cell therapy, Solid tumors, IL-15, Breast Cancer, Lung and Bronchus Cancer, Prostate Cancer, Colorectal (Colon and Rectal) Cancer, CAR-T, Non-Melanoma Skin Cancer, Melanoma, Bladder Cancer, Kidney (Renal Cell and Renal Pelvis) Cancer, Pancreatic Cancer, Stomach (Gastric) Cancer, Esophageal Cancer
- Medical subject headings
- Neoplasms, Sarcoma, Leukemia, Breast Neoplasms, Neoplasm Metastasis, Lung Neoplasms, Disease, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBNK-001 + IL-15 + PembrolizumabBiological
Also called Pembrolizumab, IL-15, EBNK-001
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 group | Role | What they receive |
|---|---|---|
| EBNK-001 + IL-15 + Pembrolizumab | Experimental | Not described Receives: Biological: EBNK-001 + IL-15 + Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measured: 30 DAYS
Incidence of Dose-Limiting Toxicities (DLTs)
Incidence of Dose-Limiting Toxicities (DLTs)
Measured: 30 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Feb 2026
- Primary completion21 Dec 2028 (estimated)
- Study completion21 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1 dose-escalation to determine MTD/RP2D using DLT monitoring in an initial safety window (commonly \~28 days). Phase 2 expansion cohorts at RP2D to estimate preliminary efficacy in selected solid tumor types.
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essen Biotech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410676
- Sponsor's protocol ID
- EB-NK-ST-001
- Acronym
- EBNK-ST-001
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07410676
- Acronym / sponsor ID
- EBNK-ST-001 / EB-NK-ST-001
- Conditions
- Cancer, Sarcoma, Leukaemia, Breast Cancer (Locally Advanced or Metastatic), Lung Cancer (Diagnosis), Colorectal Cancer
- Keywords
- Natural killer cells, NK cell therapy, Solid tumors, IL-15, Breast Cancer, Lung and Bronchus Cancer, Prostate Cancer, Colorectal (Colon and Rectal) Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Essen BiotechUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 21 Dec 2028 (estimated)
- Study completion
- 21 Dec 2029 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
EBNK-001 is an "off-the-shelf" allogeneic NK cell product intended for multi-dose administration. Participants first receive a short course of lymphodepleting chemotherapy (CY/FLU) to facilitate NK-cell expansion and persistence, followed by weekly NK-cell infusions for 3 consecutive weeks in each treatment cycle (e.g., Days 1, 8, 15). Low-dose IL-15 is administered after NK-cell infusion(s) to support NK-cell survival.
The trial includes:
Phase 1 (Dose Escalation): evaluates escalating doses of EBNK-001 to identify MTD/RP2D based on DLTs observed in the first 28 days after first NK-cell infusion (DLT window).
Phase 2 (Dose Expansion): evaluates preliminary efficacy at RP2D in selected solid tumor expansion cohorts.
Participants are followed for tumor response until progression and for survival for at least 12 months. If EBNK-001 is considered a gene-modified cell product in your program, participants may transition into a separate long-term follow-up study consistent with long-term monitoring described in NK cell therapy protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1 dose-escalation to determine MTD/RP2D using DLT monitoring in an initial safety window (commonly ~28 days). Phase 2 expansion cohorts at RP2D to estimate preliminary efficacy in selected solid tumor types.
| Arm | Type | Receives |
|---|---|---|
| EBNK-001 + IL-15 + Pembrolizumab | Experimental | Biological: EBNK-001 + IL-15 + Pembrolizumab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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):
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBNK-001 + IL-15 + PembrolizumabAlso: Pembrolizumab, IL-15, EBNK-001Biological: 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 | Biological | EBNK-001 + IL-15 + Pembrolizumab |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: 30 DAYS
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: 30 DAYS
Incidence of Dose-Limiting Toxicities (DLTs)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EBNK-001 + IL-15 + Pembrolizumab in people with Cancer and Sarcoma, run by Essen Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rhoda M Smith, Phd (2077706670, clinical-trials@essen-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (time frame: 30 DAYS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.