Health Trials

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

ConditionsCancerBreast 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
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age8-85
SponsorEssen Biotech

About this trial

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 criteria

Qualifiers

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.

Arm A: ≥1 antigen meets "positive" threshold

Arm B: ≥2 antigens meet "positive" threshold

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • EB-SELECT Single-Target CAR-NK Cells
  • Dual-Target Antigen-Selected CAR-NK

Treatment groups

85 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Essen Biotech

Lead sponsor

Source ClinicalTrials.gov