NCT07410494

Brief Summary

This Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P75+ for phase_1 cancer

Timeline
31mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Feb 2026Dec 2028

Study Start

First participant enrolled

February 1, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2028

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

February 8, 2026

Last Update Submit

February 14, 2026

Conditions

CancerBreast CancerNon-Small Cell Lung Cancer (NSCLC)Colorectal Cancer (Locally Advanced or Metastatic)Prostate Cancer - RecurrentPancreatic Ductal Adenocarcinoma (PDAC)Ovarian CancerGlioblastomaMelanoma (Skin Cancer)Acute Myeloid Leukemia (AML)Non Hodgkin LymphomaMultiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), LymphomaLiver Cancer

Keywords

CAR-NKSolid tumorDual-target CARctDNACAR-TBreast cancerNon-small cell lung cancer (NSCLC)Colorectal cancer (CRC)Prostate cancerPancreatic ductal adenocarcinoma (PDAC)Ovarian, fallopian tube, and primary peritoneal cancersGlioblastoma and other high-grade gliomasMelanomaAcute myeloid leukemia (AML)Non-Hodgkin lymphoma (NHL), especially DLBCL and follicular lymphomaMultiple myeloma (especially relapsed/refractory)Liver cancer (hepatocellular carcinoma, HCC)

Outcome Measures

Primary Outcomes (2)

  • Incidence, type, and severity of adverse events (AEs), graded by CTCAE v5.0

    28 DAYS

  • Incidence of Dose-Limiting Toxicities (DLTs)

    28 DAYS

Secondary Outcomes (2)

  • Objective Response Rate (ORR) (RECIST 1.1)

    12 months

  • Disease Control Rate (DCR)

    12 months

Study Arms (2)

Single-Target Antigen-Selected CAR-NK

EXPERIMENTAL

Participants whose profiling identifies one dominant actionable antigen.

Biological: EB-SELECT Single-Target CAR-NK Cells

Dual-Target Antigen-Selected CAR-NK

EXPERIMENTAL

Participants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity.

Biological: Dual-Target Antigen-Selected CAR-NK

Interventions

EB-SELECT Single-Target CAR-NK CellsBIOLOGICAL

Donor-derived CAR-NK cells expressing a single CAR selected from the target menu. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion. Similar conditioning drugs are used in CAR-NK solid tumor trials.

Also known as: Lymphodepleting Chemotherapy, Fludarabine, Cyclophosphamide, IL-2
Single-Target Antigen-Selected CAR-NK
Dual-Target Antigen-Selected CAR-NKBIOLOGICAL

Participants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion . Similar conditioning drugs are used in CAR-NK solid tumor trials.

Also known as: EB-SELECT Dual-Target CAR-NK Cells, Fludarabine, Cyclophosphamide, IL-2
Dual-Target Antigen-Selected CAR-NK

Eligibility Criteria

Age8 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years.
  • Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumor that is relapsed/refractory after standard therapy, or no standard therapy available.
  • Targetable antigen positivity from the protocol target menu based on:
  • tissue biopsy and/or liquid biopsy platform (as defined in the lab manual).
  • Arm assignment rules :
  • Arm A: ≥1 antigen meets "positive" threshold
  • Arm B: ≥2 antigens meet "positive" threshold
  • ECOG performance status 0-1 (or 0-2 ).
  • At least one measurable lesion by RECIST 1.1.
  • Adequate organ function (hematologic, renal, hepatic, cardiac) within protocol-defined limits.
  • Willingness to undergo blood draws and required biopsies (when medically feasible).
  • Negative pregnancy test for participants of childbearing potential; agreement to effective contraception during and after study treatment.

You may not qualify if:

  • Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period .
  • Active, uncontrolled infection requiring IV antibiotics; known uncontrolled HIV; active HBV/HCV with detectable viral load (per local policy).
  • Active CNS metastases requiring escalating steroids or urgent intervention (stable treated CNS disease may be allowed ).
  • Active autoimmune disease requiring systemic immunosuppression, or chronic systemic steroids above protocol threshold.
  • Clinically significant cardiovascular disease (e.g., recent MI, unstable arrhythmia), uncontrolled pulmonary disease, or other serious comorbidity that increases risk.
  • Major surgery or anticancer therapy too close to lymphodepletion (protocol-defined washout).
  • Pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District One Hospital

Beijing, Beijing Municipality, 086-373, China

RECRUITING

MeSH Terms

Conditions

NeoplasmsBreast NeoplasmsCarcinoma, Non-Small-Cell LungColorectal NeoplasmsNeoplasm MetastasisOvarian NeoplasmsGlioblastomaMelanomaLeukemia, Myeloid, AcuteLymphoma, Non-HodgkinMultiple MyelomaLymphomaLiver NeoplasmsProstatic NeoplasmsLymphoma, FollicularCarcinoma, Hepatocellular

Interventions

fludarabineCyclophosphamideInterleukin-2

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroendocrine TumorsNevi and MelanomasSkin NeoplasmsLeukemia, MyeloidLeukemiaHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLiver DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinoma

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsInterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Central Study Contacts

Rhoda M Smith, PHD

CONTACT

+12077706670clinical-trials@essen-biotech.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Open-label due to the nature of personalized antigen assignment and cell product differences
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2026

First Posted

February 13, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 28, 2027

Study Completion (Estimated)

December 28, 2028

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)