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Recruiting Phase 1 / Phase 2

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

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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.

Condition
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
Tested
EB-SELECT Single-Target CAR-NK Cells, Dual-Target Antigen-Selected CAR-NK
Sponsor
Essen Biotech

Who can join

Age
8 to 85 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 8 years
  • Maximum age: 85 years
  • Study condition: 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
  • 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 7

  • 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

1 site, 1 recruiting

District One Hospital

Beijing, Beijing Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.