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

Beijing Biotech

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumors; Metastatic Solid Tumors; TROP2-Expressing Solid Tumors

Treatments: Biological: EB-NK-301; Drug: Fludarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07589530

EB-NK-SOLID-019

Details and patient eligibility

About

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.

Full description

Study Overview: The study includes two parts. Part A (dose escalation) uses a standard dose-escalation design to evaluate multiple dose levels of EB-NK-301 after lymphodepleting chemotherapy. Part B (dose expansion) enrolls additional participants at the selected RP2D to further characterize safety and to estimate preliminary efficacy within selected tumor-type cohorts.

Treatment Plan: Participants receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by intravenous EB-NK-301 infusions. Participants are monitored closely for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infusion reactions, and other adverse events.

Assessments: Tumor imaging is performed every 8 weeks during the first 12 months, then every 12 weeks as clinically indicated. Blood samples are collected to assess CAR-NK cell persistence, cytokines, and other immune biomarkers.

Follow-up: Participants are followed for safety and survival for up to 24 months after first infusion.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Dose Escalation

Experimental group

Description:

Sequential dose escalation of EB-NK-301 following lymphodepleting chemotherapy to evaluate safety, DLTs, and identify RP2D.

Treatment:

Drug: Fludarabine

Biological: EB-NK-301

Dose Expansion

Experimental group

Description:

Expansion cohorts at the RP2D in selected TROP2-expressing tumor types to further assess safety and preliminary efficacy.

Treatment:

Drug: Fludarabine

Biological: EB-NK-301