ClinicalTrials.gov record NCT07589543

Dual-Target CAR-NK Cells in Recurrent or Refractory Epithelial Ovarian Cancer

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age18 years old to 75 years old
SexFemale
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1/2 study evaluates an investigational dual-target CAR‑NK cell product (EB-DUALNK) in adults with recurrent or refractory epithelial ovarian, fallopian tube, or primary peritoneal carcinoma after prior standard therapy. Before dosing, tumor tissue is tested for antigen expression to select a two-antigen target pair. Participants receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine) followed by an EB-DUALNK infusion; the study includes dose-escalation to identify a recommended Phase 2 dose and a Phase 2 expansion at that dose.

What it is studying. The study is testing the safety and tolerability of EB-DUALNK, aims to find a recommended Phase 2 dose, and will collect early evidence of anti-tumor activity and how tumor antigen patterns relate to outcomes.

What the researchers hope to learn. Identify the recommended Phase 2 dose (RP2D) and the incidence of dose-limiting toxicities; characterize adverse events and tolerability; estimate preliminary anti-tumor activity (for example, tumor response and survival measures); and study CAR‑NK cell persistence, phenotype, and the relationship between tumor antigen expression and clinical outcomes.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Cyclophosphamide
  • Fludarabine
Biological
  • EB-DUALNK

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Before dosing, participants provide tumor tissue for antigen testing. They receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine) followed by a single infusion of EB-DUALNK (dual‑target CAR‑NK cells); repeat dosing may be allowed for some cohorts if safety criteria are met. Close safety monitoring is performed for events such as cytokine release syndrome, neurotoxicity, infusion reactions, infections, and organ toxicities. Tumor response is assessed by imaging (RECIST v1.1) and CA‑125 when applicable, and blood/tissue samples are collected for correlative studies of CAR‑NK persistence, phenotype, and cytokines.

How the study is structured. An open-label, interventional Phase 1/2 study with a single treatment group. Tumor antigen testing is done before treatment to pick a dual-target pair. Phase 1 uses dose-escalation to assess short-term toxicities; Phase 2 expands at the selected dose to further study safety and responses. Treatment involves lymphodepleting chemotherapy followed by one EB-DUALNK infusion (repeat dosing may be allowed in some cohorts). No masking or control arm is used.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Epithelial Ovarian Cancer; Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum. Does it apply to my diagnosis?
  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Gaucher disease

Clinical trials64 trials listed for Gaucher diseaseEvery trial the registry lists for Gaucher disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Gaucher disease researchLatest monthly update: September 2026. Includes: Platelet release. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Mar 2, 2026
Primary completion
Mar 14, 2027 (estimated)
Study completion
Mar 17, 2028 (estimated)
Target enrollment
42 participants (estimated)
Last updated on registry
May 15, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Beijing Biotech

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

chimeric antigen receptor
A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
biomarker
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Histologically confirmed
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
standard therapy
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
ECOG performance status
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
investigational
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
Phase 1
An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
dose-escalation
Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
recommended Phase 2 dose
The dose chosen at the end of a phase 1 study for testing in later studies, based on safety and other measurements.
Phase 2
A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
cytokine release syndrome
A reaction in which the immune system releases a large amount of signalling proteins at once, causing fever and sometimes low blood pressure or breathing problems. It can occur after some immune therapies, such as CAR-T cells or bispecific antibodies.
immune effector cell-associated neurotoxicity syndrome
Nervous-system side effects, such as confusion or difficulty speaking, that can occur after some immune therapies. Usually temporary, but monitored closely.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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