Advanced Solid TumorsPhase 1/2SOLID-NKNCT07589530
Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors
A Phase 1/2 study testing EB-NK-301 and Fludarabine in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Beijing Biotech at 1 site in China.
Trial summary
study evaluates EB-NK-301, an investigational off-the-shelf allogeneic CAR-NK cell product targeting TROP2, in adults with advanced or metastatic solid tumors that express TROP2 and have progressed after standard therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors, Metastatic Solid Tumors, TROP2-Expressing Solid Tumors
- What is being tested?
- EB-NK-301 and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years at the time of informed consent.
- Histologically or cytologically confirmed advanced or metastatic solid tumor with documented TROP2 expression (per local testing or central confirmation).
- Disease progression on, intolerance to, or ineligibility for available standard therapy.
- At least one measurable lesion per RECIST 1.1.
- ECOG performance status 0 to 1.
- Adequate organ function (hematologic, renal, hepatic) within protocol-defined limits.
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- Life expectancy ≥ 12 weeks.
- Willingness to use effective contraception during study participation and for a protocol-defined period after last infusion (if of childbearing potential).
- Ability to understand and willingness to sign written informed consent.
Who cannot join
- Active central nervous system (CNS) metastases or leptomeningeal disease (unless treated and clinically stable for ≥ 4 weeks).
- Prior allogeneic hematopoietic stem cell transplant or solid organ transplant.
- Uncontrolled active infection, including uncontrolled hepatitis B, hepatitis C, or HIV infection.
- Active autoimmune disease requiring systemic immunosuppression.
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction or stroke within 6 months, uncontrolled arrhythmia).
- Receipt of another investigational agent within 2 weeks (or 5 half-lives, whichever is longer) prior to lymphodepleting chemotherapy.
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- Prior gene-modified cellular therapy within 3 months prior to enrollment.
- Systemic corticosteroid therapy > 10 mg/day prednisone equivalent within 7 days prior to lymphodepletion (excluding physiologic replacement).
- 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
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen J Peng, Phd, Zhen-Peng@beijing-biotech.com
About this study
Official title: A Phase 1/2, Open-Label, Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of EB-NK-301 (Allogeneic TROP2-Targeted CAR NK Cells) Following Lymphodepleting Chemotherapy in Adults With Advanced or Metastatic TROP2-Expressing Solid Tumors
study evaluates EB-NK-301, an investigational off-the-shelf allogeneic CAR-NK cell product targeting TROP2, in adults with advanced or metastatic solid tumors that express TROP2 and have progressed after standard therapy.
The primary goals are to assess safety and tolerability, identify dose-limiting toxicities (DLTs), and determine a recommended Phase 2 dose (RP2D). Secondary goals include preliminary anti-tumor activity, persistence of infused CAR-NK cells, and exploratory immune biomarkers.
Read the detailed description
Study Overview: The study includes two parts. Part A (dose escalation) uses a standard dose-escalation design to evaluate multiple dose levels of EB-NK-301 after lymphodepleting chemotherapy. Part B (dose expansion) enrolls additional participants at the selected RP2D to further characterize safety and to estimate preliminary efficacy within selected tumor-type cohorts.
Treatment Plan: Participants receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by intravenous EB-NK-301 infusions. Participants are monitored closely for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infusion reactions, and other adverse events.
Assessments: Tumor imaging is performed every 8 weeks during the first 12 months, then every 12 weeks as clinically indicated. Blood samples are collected to assess CAR-NK cell persistence, cytokines, and other immune biomarkers.
Follow-up: Participants are followed for safety and survival for up to 24 months after first infusion.
- Being tested
- EB-NK-301, Fludarabine
- Keywords
- Solid tumors, Immunotherapy, Adoptive cell therapy, Natural killer cells, NK cell therapy, CAR-NK, Dose escalation, Dose expansion, TROP2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-NK-301Biological
Also called TROP2-CAR NK
Investigational allogeneic CAR-NK cell product targeting TROP2, administered by intravenous infusion.
FludarabineDrug
Lymphodepleting chemotherapy administered prior to EB-NK-301 infusion to facilitate immune cell engraftment and persistence.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Sequential dose escalation of EB-NK-301 following lymphodepleting chemotherapy to evaluate safety, DLTs, and identify RP2D. Receives: Biological: EB-NK-301; Drug: Fludarabine |
| Dose Expansion | Experimental | Expansion cohorts at the RP2D in selected TROP2-expressing tumor types to further assess safety and preliminary efficacy. Receives: Biological: EB-NK-301; 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) (CTCAE v5.0)
Measured: 28 days
Incidence and severity of treatment-emergent adverse events (AEs)
Measured: 12 months
Recommended Phase 2 dose (RP2D) of EB-NK-301
Measured: 6 months
Secondary outcomes (3)
Objective response rate (ORR) per RECIST 1.1
Measured: 12 months
Duration of response (DoR)
Measured: 24 months
Overall survival (OS)
Measured: 24 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 Feb 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 Advanced Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part A: dose escalation (sequential dose levels). Part B: dose expansion at RP2D in selected tumor cohorts.
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT07589530
- Sponsor's protocol ID
- EB-NK-SOLID-019
- Acronym
- SOLID-NK
- 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 Dose-Expansion Study Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of EB-NK-301 (Allogeneic TROP2-Targeted CAR NK Cells) Following Lymphodepleting Chemotherapy in Adults With Advanced or Metastatic TROP2-Expressing Solid Tumors
- ClinicalTrials.gov ID
- NCT07589530
- Acronym / sponsor ID
- SOLID-NK / EB-NK-SOLID-019
- Keywords
- Solid tumors, Immunotherapy, Adoptive cell therapy, Natural killer cells, NK cell therapy, CAR-NK, Dose escalation, Dose expansion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 14 Feb 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.
study evaluates EB-NK-301, an investigational off-the-shelf allogeneic CAR-NK cell product targeting TROP2, in adults with advanced or metastatic solid tumors that express TROP2 and have progressed after standard therapy.
The primary goals are to assess safety and tolerability, identify dose-limiting toxicities (DLTs), and determine a recommended Phase 2 dose (RP2D). Secondary goals include preliminary anti-tumor activity, persistence of infused CAR-NK cells, and exploratory immune biomarkers.
Detailed description
Study Overview: The study includes two parts. Part A (dose escalation) uses a standard dose-escalation design to evaluate multiple dose levels of EB-NK-301 after lymphodepleting chemotherapy. Part B (dose expansion) enrolls additional participants at the selected RP2D to further characterize safety and to estimate preliminary efficacy within selected tumor-type cohorts.
Treatment Plan: Participants receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by intravenous EB-NK-301 infusions. Participants are monitored closely for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infusion reactions, and other adverse events.
Assessments: Tumor imaging is performed every 8 weeks during the first 12 months, then every 12 weeks as clinically indicated. Blood samples are collected to assess CAR-NK cell persistence, cytokines, and other immune biomarkers.
Follow-up: Participants are followed for safety and survival for up to 24 months after first infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part A: dose escalation (sequential dose levels). Part B: dose expansion at RP2D in selected tumor cohorts.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Biological: EB-NK-301, Drug: FludarabineSequential dose escalation of EB-NK-301 following lymphodepleting chemotherapy to evaluate safety, DLTs, and identify RP2D. |
| Dose Expansion | Experimental | Biological: EB-NK-301, Drug: FludarabineExpansion cohorts at the RP2D in selected TROP2-expressing tumor types to further assess safety and preliminary efficacy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 to 75 years at the time of informed consent.
- Histologically or cytologically confirmed advanced or metastatic solid tumor with documented TROP2 expression (per local testing or central confirmation).
- Disease progression on, intolerance to, or ineligibility for available standard therapy.
- At least one measurable lesion per RECIST 1.1.
- ECOG performance status 0 to 1.
Key exclusion criteria (9 listed)
- Active central nervous system (CNS) metastases or leptomeningeal disease (unless treated and clinically stable for ≥ 4 weeks).
- Prior allogeneic hematopoietic stem cell transplant or solid organ transplant.
- Uncontrolled active infection, including uncontrolled hepatitis B, hepatitis C, or HIV infection.
- Active autoimmune disease requiring systemic immunosuppression.
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction or stroke within 6 months, uncontrolled arrhythmia).
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-NK-301Also: TROP2-CAR NKInvestigational allogeneic CAR-NK cell product targeting TROP2, administered by intravenous infusion. | Biological | Dose Escalation, Dose Expansion |
| FludarabineLymphodepleting chemotherapy administered prior to EB-NK-301 infusion to facilitate immune cell engraftment and persistence. | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Incidence of dose-limiting toxicities (DLTs) (CTCAE v5.0)
Time frame: 28 days
Incidence and severity of treatment-emergent adverse events (AEs)
Time frame: 12 months
Recommended Phase 2 dose (RP2D) of EB-NK-301
Time frame: 6 months
3 secondary outcomes
Objective response rate (ORR) per RECIST 1.1
Time frame: 12 months
Duration of response (DoR)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 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-NK-301 and Fludarabine in people with Advanced Solid Tumors and Metastatic Solid Tumors, 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 9 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 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) (CTCAE v5.0) (time frame: 28 days). The study lists 3 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.