Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors
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.
Conditions studied
Cancer, Breast Cancer, Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (Locally Advanced or Metastatic), Prostate Cancer - Recurrent, Pancreatic Ductal Adenocarcinoma (PDAC), Ovarian Cancer, Glioblastoma, Melanoma (Skin Cancer), Acute Myeloid Leukemia (AML), Non Hodgkin Lymphoma, Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma, Liver Cancer
About this study
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.
Interventions
- 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.
- 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.
Primary outcomes
- Incidence, type, and severity of adverse events (AEs), graded by CTCAE v5.0 (28 DAYS)
- Incidence of Dose-Limiting Toxicities (DLTs) (28 DAYS)
Eligibility information
Study locations
- District One Hospital, Beijing, Beijing Municipality 086-373 China
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.