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

Sponsor
Essen Biotech
Study ID
NCT07410494
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia (AML)
  • Breast Cancer
  • Cancer
  • Colorectal Cancer (Locally Advanced or Metastatic)
  • Glioblastoma
  • Liver Cancer
  • Melanoma (Skin Cancer)
  • Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma
  • Non Hodgkin Lymphoma
  • Non-Small Cell Lung Cancer (NSCLC)
  • Ovarian Cancer
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Prostate Cancer - Recurrent

Eligibility Criteria

Sex
ALL
Age
8 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • EB-SELECT Single-Target CAR-NK Cells — BIOLOGICAL
    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 — BIOLOGICAL
    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 Details

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 Dates

First listed
Feb 13, 2026
Start date
Feb 1, 2026
Status verified
Feb 2026
Primary completion
Dec 28, 2027
Completion
Dec 28, 2028

Study Design

Enrollment
85 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Single-Target Antigen-Selected CAR-NK
    Participants whose profiling identifies one dominant actionable antigen.
  • Experimental: Dual-Target Antigen-Selected CAR-NK
    Participants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity.

Primary Outcome Measure

Incidence, type, and severity of adverse events (AEs), graded by CTCAE v5.0 [ Time Frame: 28 DAYS ]

Central Contacts

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