Epithelial Ovarian CancerPhase 1/2EB-DUALNK-OVNCT07589543
Dual-Target CAR-NK Cells in Recurrent or Refractory Epithelial Ovarian Cancer
A Phase 1/2 study testing EB-DUALNK, Cyclophosphamide and Fludarabine in people with Epithelial Ovarian Cancer and Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum, run by Beijing Biotech at 1 site in China.
Trial summary
This study evaluates the safety, tolerability, and preliminary anti-tumor activity of EB-DUALNK, a dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy, in adults with recurrent or refractory epithelial ovarian cancer. Candidates for targeting include GD2, MUC1, PSMA, and mesothelin. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum
- What is being tested?
- EB-DUALNK, Cyclophosphamide and Fludarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2026to 17 Mar 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years; able to provide written informed consent.
- Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma that is recurrent or refractory after standard therapy (at least 2 prior systemic regimens), with measurable disease per RECIST v1.1 and ECOG performance status 0-1.
- Tumor tissue available for antigen assessment. Participant must meet protocol-defined positivity for the selected dual-target pair (example: 1 target expressed in >=50% of tumor cells by IHC and the second target in >=20%).
- Adequate organ function per protocol-specified labs; negative pregnancy test nd agrees to use effective contraception for a protocol-defined period after infusion.
Who cannot join
- Active CNS metastases or carcinomatous meningitis (unless treated and stable for a protocol-defined period).
- Prior gene-modified cell therapy targeting any of the study antigens (GD2, MUC1, PSMA, mesothelin) within 6 months.
- Uncontrolled active infection (including uncontrolled HIV, HBV, or HCV) or active systemic fungal infection.
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction, unstable angina, uncontrolled arrhythmia) or LVEF <50% .
- Active autoimmune disease requiring systemic immunosuppression within 14 days prior to lymphodepletion (physiologic steroid replacement permitted).
- History of organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Pregnant or breastfeeding.
- Any condition that, in the investigator's judgment, would compromise participant safety or compliance.
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
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com
About this study
Official title: A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of Dual-Target CAR-NK Cells (EB-DUALNK) Following Lymphodepleting Chemotherapy in Adults With Recurrent or Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
This study evaluates the safety, tolerability, and preliminary anti-tumor activity of EB-DUALNK, a dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy, in adults with recurrent or refractory epithelial ovarian cancer. Candidates for targeting include GD2, MUC1, PSMA, and mesothelin. After baseline biomarker assessment (tumor antigen expression), the program will select the most suitable dual-target pair for clinical testing. Participants will receive lymphodepleting chemotherapy followed by EB-DUALNK infusion and safety/response follow-up.
Read the detailed description
EB-DUALNK is an investigational, genetically engineered NK-cell product designed to recognize tumor cells through two surface antigens. Dual targeting is intended to reduce antigen-escape and improve tumor recognition in heterogeneous solid tumors. Prior to first patient dosing, a biomarker assessment will review ovarian tumor expression patterns for GD2, MUC1, PSMA, and mesothelin (using immunohistochemistry and/or flow cytometry where feasible). The final dual-target pair will be chosen based on a pre-specified decision framework (antigen prevalence, co-expression, safety rationale, and manufacturing feasibility). The study includes a Phase 1 dose-escalation portion to identify the recommended Phase 2 dose (RP2D) and a Phase 2 expansion portion to further characterize safety and estimate preliminary efficacy at the RP2D.
Participants will receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine) followed by a single infusion of EB-DUALNK. Repeat dosing may be permitted in selected cohorts if protocol-defined safety criteria are met. Safety monitoring includes assessment of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infusion reactions, infections, and organ toxicities. Efficacy assessments include radiographic response by RECIST v1.1 and CA-125 (where applicable). Correlative studies evaluate CAR-NK persistence, phenotype, cytokines, and relationships between antigen expression and clinical outcomes.
- Being tested
- EB-DUALNK, Cyclophosphamide, Fludarabine
- Keywords
- Solid tumor, Ovarian cancer, Immunotherapy, Adoptive cell therapy, CAR-NK, Dual-target, GD2, MUC1, PSMA, Mesothelin
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-DUALNKBiological
(dual-target CAR-NK cells; selected antigen pair from GD2, MUC1, PSMA, mesothelin)
CyclophosphamideDrug
lymphodepletion
FludarabineDrug
lymphodepletion
| Study group | Role | What they receive |
|---|---|---|
| EB-DUALNK following lymphodepleting chemotherapy | Experimental | Not described Receives: Biological: EB-DUALNK; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs) to determine maximum tolerated dose (MTD)
Measured: 28 days
Incidence, severity, and relatedness of adverse events (AEs)
Measured: 28 days
Secondary outcomes (2)
Objective response rate (ORR) per RECIST v1.1.
Measured: 12 months
Overall survival (OS)
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 posted15 May 2026
- Study start2 Mar 2026
- Primary completion14 Mar 2027 (estimated)
- Study completion17 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Beijing BiotechThe sponsor's other registered studies.
- 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
- Part A: Dose escalation (3+3 design) of EB-DUALNK after lymphodepletion to determine DLTs and RP2D. Part B: Dose expansion at RP2D to further characterize safety and estimate preliminary efficacy.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589543
- Sponsor's protocol ID
- EB-OVCA-DUALNK-118
- Acronym
- EB-DUALNK-OV
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of Dual-Target CAR-NK Cells (EB-DUALNK) Following Lymphodepleting Chemotherapy in Adults With Recurrent or Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
- ClinicalTrials.gov ID
- NCT07589543
- Acronym / sponsor ID
- EB-DUALNK-OV / EB-OVCA-DUALNK-118
- Keywords
- Solid tumor, Ovarian cancer, Immunotherapy, Adoptive cell therapy, CAR-NK, Dual-target, GD2, MUC1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Beijing BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 14 Mar 2027 (estimated)
- Study completion
- 17 Mar 2028 (estimated)
- First posted
- 15 May 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 study evaluates the safety, tolerability, and preliminary anti-tumor activity of EB-DUALNK, a dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy, in adults with recurrent or refractory epithelial ovarian cancer. Candidates for targeting include GD2, MUC1, PSMA, and mesothelin. After baseline biomarker assessment (tumor antigen expression), the program will select the most suitable dual-target pair for clinical testing. Participants will receive lymphodepleting chemotherapy followed by EB-DUALNK infusion and safety/response follow-up.
Detailed description
EB-DUALNK is an investigational, genetically engineered NK-cell product designed to recognize tumor cells through two surface antigens. Dual targeting is intended to reduce antigen-escape and improve tumor recognition in heterogeneous solid tumors. Prior to first patient dosing, a biomarker assessment will review ovarian tumor expression patterns for GD2, MUC1, PSMA, and mesothelin (using immunohistochemistry and/or flow cytometry where feasible). The final dual-target pair will be chosen based on a pre-specified decision framework (antigen prevalence, co-expression, safety rationale, and manufacturing feasibility). The study includes a Phase 1 dose-escalation portion to identify the recommended Phase 2 dose (RP2D) and a Phase 2 expansion portion to further characterize safety and estimate preliminary efficacy at the RP2D.
Participants will receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine) followed by a single infusion of EB-DUALNK. Repeat dosing may be permitted in selected cohorts if protocol-defined safety criteria are met. Safety monitoring includes assessment of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infusion reactions, infections, and organ toxicities. Efficacy assessments include radiographic response by RECIST v1.1 and CA-125 (where applicable). Correlative studies evaluate CAR-NK persistence, phenotype, cytokines, and relationships between antigen expression and clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Part A: Dose escalation (3+3 design) of EB-DUALNK after lymphodepletion to determine DLTs and RP2D. Part B: Dose expansion at RP2D to further characterize safety and estimate preliminary efficacy.
| Arm | Type | Receives |
|---|---|---|
| EB-DUALNK following lymphodepleting chemotherapy | Experimental | Biological: EB-DUALNK, Drug: Cyclophosphamide, Drug: Fludarabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years; able to provide written informed consent.
- Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma that is recurrent or refractory after standard therapy (at least 2 prior systemic regimens), with measurable disease per RECIST v1.1 and ECOG performance status 0-1.
- Tumor tissue available for antigen assessment. Participant must meet protocol-defined positivity for the selected dual-target pair (example: 1 target expressed in >=50% of tumor cells by IHC and the second target in >=20%).
- Adequate organ function per protocol-specified labs; negative pregnancy test nd agrees to use effective contraception for a protocol-defined period after infusion.
Key exclusion criteria (8 listed)
- Active CNS metastases or carcinomatous meningitis (unless treated and stable for a protocol-defined period).
- Prior gene-modified cell therapy targeting any of the study antigens (GD2, MUC1, PSMA, mesothelin) within 6 months.
- Uncontrolled active infection (including uncontrolled HIV, HBV, or HCV) or active systemic fungal infection.
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction, unstable angina, uncontrolled arrhythmia) or LVEF <50% .
- Active autoimmune disease requiring systemic immunosuppression within 14 days prior to lymphodepletion (physiologic steroid replacement permitted).
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-DUALNK(dual-target CAR-NK cells; selected antigen pair from GD2, MUC1, PSMA, mesothelin) | Biological | EB-DUALNK following lymphodepleting chemotherapy |
| Cyclophosphamidelymphodepletion | Drug | EB-DUALNK following lymphodepleting chemotherapy |
| Fludarabinelymphodepletion | Drug | EB-DUALNK following lymphodepleting chemotherapy |
Primary outcome
Incidence of dose-limiting toxicities (DLTs) to determine maximum tolerated dose (MTD)
Time frame: 28 days
Incidence, severity, and relatedness of adverse events (AEs)
Time frame: 28 days
2 secondary outcomes
Objective response rate (ORR) per RECIST v1.1.
Time frame: 12 months
Overall survival (OS)
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 15 May 2026.
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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-DUALNK, Cyclophosphamide and Fludarabine in people with Epithelial Ovarian Cancer and Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum, run by Beijing 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 4 inclusion and 8 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 15 May 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 shan S Lu, Phd (+86 13076790030, Seni-Lu@beijing-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) to determine maximum tolerated dose (MTD) (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 15 May 2026.