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Clinical Trials in China / NCT07410494
Recruiting Phase 1/2

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

NCT07410494 · tracked via the Priya Life Science China tracker
Sponsor
Essen Biotech
Phase
Phase 1/2
Started
2026-02-01
Last updated
2026-02-18

Condition(s) studied

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

Investigational drug(s) / intervention(s)

EB-SELECT Single-Target CAR-NK CellsDual-Target Antigen-Selected CAR-NK

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
8 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
District One Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07410494 on ClinicalTrials.gov ↗ ← All trials in China