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

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. 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.

Eligibility

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.

Conditions4

Interventions2

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