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

NCT07589530 | Recruiting Phase 1 DMC

• 1 other identifier: EB-NK-SOLID-019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Solid tumors; Immunotherapy; Adoptive cell therapy; Natural killer cells; NK cell therapy; CAR-NK; Dose escalation; Dose expansion; TROP2

Outcome Measures

Primary Outcomes (3)

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

  28 days

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

  12 months

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

  6 months

Secondary Outcomes (3)

• Objective response rate (ORR) per RECIST 1.1

  12 months

• Duration of response (DoR)

  24 months

• Overall survival (OS)

  24 months

Study Arms (2)

Dose Escalation

EXPERIMENTAL

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

Biological: EB-NK-301; Drug: Fludarabine

Dose Expansion

EXPERIMENTAL

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

Biological: EB-NK-301; Drug: Fludarabine

Interventions

EB-NK-301 BIOLOGICAL

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

Also known as: TROP2-CAR NK

Dose Escalation; Dose Expansion

Fludarabine DRUG

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

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Beijing Biotech: lead

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

MeSH Terms

Interventions

fludarabine

Central Study Contacts

shan S Lu, Phd

CONTACT

+86 13076790030; Seni-Lu@beijing-biotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open-label study. Participants, investigators, and study staff are aware of the assigned intervention.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A: dose escalation (sequential dose levels). Part B: dose expansion at RP2D in selected tumor cohorts.

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 15, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): March 17, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

CN (1)