Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors
Recruiting · NCT07410494 · Interventional (participants receive a specific treatment) · Lead sponsor: Essen Biotech
View the official record on ClinicalTrials.gov →Interventions studied
Dual-Target Antigen-Selected CAR-NKEB-SELECT Single-Target CAR-NK Cells
What this trial is about
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.
Who can take part
Age range
8 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
3 locations listed.
- District One Hospital - Beijing, Beijing Municipality, China
- District One Hospital - Beijing, Beijing Municipality, China
- District One Hospital - Beijing, Beijing Municipality, China