CancerPhase 1/2SELECT-CAR-NKNCT07410494
Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors
A Phase 1/2 study testing EB-SELECT Single-Target CAR-NK Cells and Dual-Target Antigen-Selected CAR-NK in people with Cancer and Breast Cancer, run by Essen Biotech at 1 site in China.
Trial summary
This Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy. Read more about this study
- Who is it for?
- Ages 8 to 85 years
- Conditions the study is for
- Cancer, Breast Cancer, Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- EB-SELECT Single-Target CAR-NK Cells and Dual-Target Antigen-Selected CAR-NK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 28 Dec 2028
- 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 8 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 18-75 years.
- Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumor that is relapsed/refractory after standard therapy, or no standard therapy available.
- Targetable antigen positivity from the protocol target menu based on:
- tissue biopsy and/or liquid biopsy platform (as defined in the lab manual).
- Arm assignment rules :
- Arm A: ≥1 antigen meets "positive" threshold
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- Arm B: ≥2 antigens meet "positive" threshold
- ECOG performance status 0-1 (or 0-2 ).
- At least one measurable lesion by RECIST 1.1.
- Adequate organ function (hematologic, renal, hepatic, cardiac) within protocol-defined limits.
- Willingness to undergo blood draws and required biopsies (when medically feasible).
- Negative pregnancy test for participants of childbearing potential; agreement to effective contraception during and after study treatment.
Who cannot join
- Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period .
- Active, uncontrolled infection requiring IV antibiotics; known uncontrolled HIV; active HBV/HCV with detectable viral load (per local policy).
- Active CNS metastases requiring escalating steroids or urgent intervention (stable treated CNS disease may be allowed ).
- Active autoimmune disease requiring systemic immunosuppression, or chronic systemic steroids above protocol threshold.
- Clinically significant cardiovascular disease (e.g., recent MI, unstable arrhythmia), uncontrolled pulmonary disease, or other serious comorbidity that increases risk.
- Major surgery or anticancer therapy too close to lymphodepletion (protocol-defined washout).
- Pregnant or breastfeeding.
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, MD, +14012275001, SFM@districtonehospital.com
About this study
Official title: A Phase 1/2, Open-Label, Biomarker-Driven Study of Allogeneic Donor-Derived CAR-NK Cells With Antigen Selection by Tissue Biopsy and/or Liquid Biopsy Profiling in Participants With Relapsed/Refractory Advanced Solid Tumors (Single-Target vs Dual-Target Strategy)
This Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.
Read the detailed description
This is an open-label, biomarker-driven adoptive cell therapy study.
Screening / Target Selection (Precision Step):
Participants undergo tumor antigen profiling using:
Tissue biopsy (preferred when safely feasible), and/or Liquid biopsy (e.g., circulating tumor DNA plus circulating tumor cells/exosome protein assay, as available in the platform).
Antigen profiling determines eligibility and assigns participants to:
Single-target CAR-NK if one antigen meets positivity thresholds, or Dual-target CAR-NK if two antigens meet thresholds or if heterogeneity is suspected.
Pre-specified target menu :
TROP2, Mesothelin (MSLN), B7-H3 (CD276), HER2, EGFR, GD2, Claudin18.2, GPC3, PSMA ("Target menu" can be expanded in amendments.)
Cell Source / Manufacturing Concept:
NK cells are obtained from a healthy allogeneic donor (unrelated or partially matched per site policy).
Donor NK cells are collected by leukapheresis, activated/expanded, and genetically modified to express:
a single CAR (Arm A) or a dual CAR / dual-target construct (Arm B). Final product is cryopreserved and released after sterility/identity/potency testing.
Conditioning \& Treatment:
Participants receive lymphodepleting chemotherapy followed by CAR-NK infusion(s). Many CAR-NK solid-tumor trials use conditioning regimens such as fludarabine and cyclophosphamide before infusion.
Optional cytokine support (e.g., low-dose IL-2) may be used per protocol to support NK persistence, consistent with approaches used in some CAR-NK studies.
Follow-up:
Intensive safety monitoring during the first 28 days. Tumor imaging at protocol-defined intervals. Correlative studies including CAR-NK persistence and ctDNA dynamics.
- Conditions
- Cancer, Breast Cancer, Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (Locally Advanced or Metastatic), Prostate Cancer - Recurrent, Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- EB-SELECT Single-Target CAR-NK Cells, Dual-Target Antigen-Selected CAR-NK
- Keywords
- CAR-NK, Solid tumor, Dual-target CAR, ctDNA, CAR-T, Breast cancer, Non-small cell lung cancer (NSCLC), Colorectal cancer (CRC), Prostate cancer, Pancreatic ductal adenocarcinoma (PDAC), Ovarian, fallopian tube, and primary peritoneal cancers, Glioblastoma and other high-grade gliomas, Melanoma, Acute myeloid leukemia (AML), Non-Hodgkin lymphoma (NHL), especially DLBCL and follicular lymphoma, Multiple myeloma (especially relapsed/refractory), Liver cancer (hepatocellular carcinoma, HCC)
- Medical subject headings
- Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Glioblastoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-SELECT Single-Target CAR-NK CellsBiological
Also called Lymphodepleting Chemotherapy, Fludarabine, Cyclophosphamide, IL-2
Donor-derived CAR-NK cells expressing a single CAR selected from the target menu. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion. Similar conditioning drugs are used in CAR-NK solid tumor trials.
Dual-Target Antigen-Selected CAR-NKBiological
Also called EB-SELECT Dual-Target CAR-NK Cells, Fludarabine, Cyclophosphamide, IL-2
Participants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion . Similar conditioning drugs are used in CAR-NK solid tumor trials.
| Study group | Role | What they receive |
|---|---|---|
| Single-Target Antigen-Selected CAR-NK | Experimental | Participants whose profiling identifies one dominant actionable antigen. Receives: Biological: EB-SELECT Single-Target CAR-NK Cells |
| Dual-Target Antigen-Selected CAR-NK | Experimental | Participants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity. Receives: Biological: Dual-Target Antigen-Selected CAR-NK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, type, and severity of adverse events (AEs), graded by CTCAE v5.0
Measured: 28 DAYS
Incidence of Dose-Limiting Toxicities (DLTs)
Measured: 28 DAYS
Secondary outcomes (2)
Objective Response Rate (ORR) (RECIST 1.1)
Measured: 12 months
Disease Control Rate (DCR)
Measured: 12 months
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 completion28 Dec 2027 (estimated)
- Study completion28 Dec 2028 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 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
- NCT07410494
- Sponsor's protocol ID
- EB-CARNK-S002
- Acronym
- SELECT-CAR-NK
- Status last verified
- Feb 2026
- First submitted
- 8 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
- A Phase 1/2, Open-Label, Biomarker-Driven Study of Allogeneic Donor-Derived CAR-NK Cells With Antigen Selection by Tissue Biopsy and/or Liquid Biopsy Profiling in Participants With Relapsed/Refractory Advanced Solid Tumors (Single-Target vs Dual-Target Strategy)
- ClinicalTrials.gov ID
- NCT07410494
- Acronym / sponsor ID
- SELECT-CAR-NK / EB-CARNK-S002
- Conditions
- Cancer, Breast Cancer, Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (Locally Advanced or Metastatic), Prostate Cancer - Recurrent, Pancreatic Ductal Adenocarcinoma (PDAC)
- Keywords
- CAR-NK, Solid tumor, Dual-target CAR, ctDNA, CAR-T, Breast cancer, Non-small cell lung cancer (NSCLC), Colorectal cancer (CRC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Essen BiotechUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 28 Dec 2028 (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, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.
Detailed description
This is an open-label, biomarker-driven adoptive cell therapy study.
Screening / Target Selection (Precision Step):
Participants undergo tumor antigen profiling using:
Tissue biopsy (preferred when safely feasible), and/or Liquid biopsy (e.g., circulating tumor DNA plus circulating tumor cells/exosome protein assay, as available in the platform).
Antigen profiling determines eligibility and assigns participants to:
Single-target CAR-NK if one antigen meets positivity thresholds, or Dual-target CAR-NK if two antigens meet thresholds or if heterogeneity is suspected.
Pre-specified target menu :
TROP2, Mesothelin (MSLN), B7-H3 (CD276), HER2, EGFR, GD2, Claudin18.2, GPC3, PSMA ("Target menu" can be expanded in amendments.)
Cell Source / Manufacturing Concept:
NK cells are obtained from a healthy allogeneic donor (unrelated or partially matched per site policy).
Donor NK cells are collected by leukapheresis, activated/expanded, and genetically modified to express:
a single CAR (Arm A) or a dual CAR / dual-target construct (Arm B). Final product is cryopreserved and released after sterility/identity/potency testing.
Conditioning \& Treatment:
Participants receive lymphodepleting chemotherapy followed by CAR-NK infusion(s). Many CAR-NK solid-tumor trials use conditioning regimens such as fludarabine and cyclophosphamide before infusion.
Optional cytokine support (e.g., low-dose IL-2) may be used per protocol to support NK persistence, consistent with approaches used in some CAR-NK studies.
Follow-up:
Intensive safety monitoring during the first 28 days. Tumor imaging at protocol-defined intervals. Correlative studies including CAR-NK persistence and ctDNA dynamics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Target Antigen-Selected CAR-NK | Experimental | Biological: EB-SELECT Single-Target CAR-NK CellsParticipants whose profiling identifies one dominant actionable antigen. |
| Dual-Target Antigen-Selected CAR-NK | Experimental | Biological: Dual-Target Antigen-Selected CAR-NKParticipants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity. |
Who may qualify
- Ages
- 8 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-75 years.
- Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumor that is relapsed/refractory after standard therapy, or no standard therapy available.
- Targetable antigen positivity from the protocol target menu based on:
- tissue biopsy and/or liquid biopsy platform (as defined in the lab manual).
- Arm assignment rules :
Key exclusion criteria (7 listed)
- Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period .
- Active, uncontrolled infection requiring IV antibiotics; known uncontrolled HIV; active HBV/HCV with detectable viral load (per local policy).
- Active CNS metastases requiring escalating steroids or urgent intervention (stable treated CNS disease may be allowed ).
- Active autoimmune disease requiring systemic immunosuppression, or chronic systemic steroids above protocol threshold.
- Clinically significant cardiovascular disease (e.g., recent MI, unstable arrhythmia), uncontrolled pulmonary disease, or other serious comorbidity that increases risk.
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 |
|---|---|---|
| EB-SELECT Single-Target CAR-NK CellsAlso: Lymphodepleting Chemotherapy, Fludarabine, Cyclophosphamide, IL-2Donor-derived CAR-NK cells expressing a single CAR selected from the target menu. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion. Similar conditioning drugs are used in CAR-NK solid tumor trials. | Biological | Single-Target Antigen-Selected CAR-NK |
| Dual-Target Antigen-Selected CAR-NKAlso: EB-SELECT Dual-Target CAR-NK Cells, Fludarabine, Cyclophosphamide, IL-2Participants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion . Similar conditioning drugs are used in CAR-NK solid tumor trials. | Biological | Dual-Target Antigen-Selected CAR-NK |
Primary outcome
Incidence, type, and severity of adverse events (AEs), graded by CTCAE v5.0
Time frame: 28 DAYS
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: 28 DAYS
2 secondary outcomes
Objective Response Rate (ORR) (RECIST 1.1)
Time frame: 12 months
Disease Control Rate (DCR)
Time frame: 12 months
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 EB-SELECT Single-Target CAR-NK Cells and Dual-Target Antigen-Selected CAR-NK in people with Cancer and Breast Cancer, 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 12 inclusion and 7 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 (+12077706670, 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, type, and severity of adverse events (AEs), graded by CTCAE v5.0 (time frame: 28 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.