Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors, Metastatic Solid Tumors, TROP2-Expressing Solid Tumors

In brief

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.

Key facts

Study ID

NCT07589530

Run by

Beijing Biotech

People needed

60

Starts

2026-03-02

Expected to finish

2028-03-17

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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