Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors (SELECT-CAR-NK)

February 14, 2026 updated by: Essen Biotech

A Phase 1/2, Open-Label, Biomarker-Driven Study of Allogeneic Donor-Derived CAR-NK Cells With Antigen Selection by Tissue Biopsy and/or Liquid Biopsy Profiling in Participants With Relapsed/Refractory Advanced Solid Tumors (Single-Target vs Dual-Target Strategy)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, biomarker-driven adoptive cell therapy study.

Screening / Target Selection (Precision Step):

Participants undergo tumor antigen profiling using:

Tissue biopsy (preferred when safely feasible), and/or Liquid biopsy (e.g., circulating tumor DNA plus circulating tumor cells/exosome protein assay, as available in the platform).

Antigen profiling determines eligibility and assigns participants to:

Single-target CAR-NK if one antigen meets positivity thresholds, or Dual-target CAR-NK if two antigens meet thresholds or if heterogeneity is suspected.

Pre-specified target menu :

TROP2, Mesothelin (MSLN), B7-H3 (CD276), HER2, EGFR, GD2, Claudin18.2, GPC3, PSMA ("Target menu" can be expanded in amendments.)

Cell Source / Manufacturing Concept:

NK cells are obtained from a healthy allogeneic donor (unrelated or partially matched per site policy).

Donor NK cells are collected by leukapheresis, activated/expanded, and genetically modified to express:

a single CAR (Arm A) or a dual CAR / dual-target construct (Arm B). Final product is cryopreserved and released after sterility/identity/potency testing.

Conditioning & Treatment:

Participants receive lymphodepleting chemotherapy followed by CAR-NK infusion(s). Many CAR-NK solid-tumor trials use conditioning regimens such as fludarabine and cyclophosphamide before infusion.

Optional cytokine support (e.g., low-dose IL-2) may be used per protocol to support NK persistence, consistent with approaches used in some CAR-NK studies.

Follow-up:

Intensive safety monitoring during the first 28 days. Tumor imaging at protocol-defined intervals. Correlative studies including CAR-NK persistence and ctDNA dynamics.

Study Type

Interventional

Enrollment (Estimated)

85

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 086-373

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-Target Antigen-Selected CAR-NK
Participants whose profiling identifies one dominant actionable antigen.
Biological: EB-SELECT Single-Target CAR-NK Cells
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.
Other Names:
  • IL-2
  • Cyclophosphamide
  • Fludarabine
  • Lymphodepleting Chemotherapy
Experimental: Dual-Target Antigen-Selected CAR-NK
Participants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity.
Biological: Dual-Target Antigen-Selected CAR-NK
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.
Other Names:
  • IL-2
  • Cyclophosphamide
  • Fludarabine
  • EB-SELECT Dual-Target CAR-NK Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence, type, and severity of adverse events (AEs), graded by CTCAE v5.0
Time Frame: 28 DAYS
28 DAYS
Incidence of Dose-Limiting Toxicities (DLTs)
Time Frame: 28 DAYS
28 DAYS

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease Control Rate (DCR)
Time Frame: 12 months
12 months
Objective Response Rate (ORR) (RECIST 1.1)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Essen Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

December 28, 2027

Study Completion (Estimated)

December 28, 2028

Study Registration Dates

First Submitted

February 8, 2026

First Submitted That Met QC Criteria

February 8, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 14, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EB-CARNK-S002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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