TROP2-targeted CAR-NK cell therapy for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1/2 interventional trial evaluating safety, tolerability, and preliminary efficacy of EB-NK-301, an allogeneic CAR-NK cell product targeting TROP2. The study uses a two-part design: a dose-escalation phase to identify a recommended Phase 2 dose after lymphodepleting chemotherapy, followed by a dose-expansion phase in selected tumor cohorts. Participants receive lymphodepletion followed by intravenous EB-NK-301 infusions and are monitored for adverse events, including CRS and ICANS, with tumor imaging every 8-12 weeks and biomarker assessments to understand persistence and immune response. Follow-up continues for up to 24 months after first infusion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.
* 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.

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: shan S Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.