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

Recruiting now · Phase 1/Phase 2

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

In brief

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.

Key facts

Study ID

NCT07410494

Run by

Essen Biotech

People needed

85

Starts

2026-02-01

Expected to finish

2028-12-28

Last updated by the study team

2026-02-18

Who can join

Age: 8 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• District One Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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