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

ConditionsAdvanced Solid TumorsMetastatic Solid TumorsTROP2-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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • EB-NK-301

    Biological/Vaccine

    Investigational allogeneic CAR-NK cell product targeting TROP2, administered by intravenous infusion.

  • Fludarabine

    Drug

    Lymphodepleting chemotherapy administered prior to EB-NK-301 infusion to facilitate immune cell engraftment and persistence.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Dose EscalationExperimental treatment 2 interventions
Group B: Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities (DLTs) (CTCAE v5.0)

Time frame
28 days
2

Incidence and severity of treatment-emergent adverse events (AEs)

Time frame
12 months
3

Recommended Phase 2 dose (RP2D) of EB-NK-301

Time frame
6 months

Secondary outcomes

1

Objective response rate (ORR) per RECIST 1.1

Time frame
12 months
2

Duration of response (DoR)

Time frame
24 months
3

Overall survival (OS)

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Biotech

Lead sponsor

Source ClinicalTrials.gov
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