Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Biotech
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- EB-NK-301
- Fludarabine
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov