Actively Recruiting
Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors
Led by Essen Biotech · Updated on 2026-02-18
85
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Histologically or cytologically confirmed advanced, unresectable, or metastatic solid tumor that is relapsed or refractory after standard therapy, or no standard therapy available
- Positive target antigen(s) based on tissue biopsy and/or liquid biopsy per protocol thresholds
- Assignment to single-target CAR-NK if at least one antigen is positive; dual-target CAR-NK if two or more antigens are positive
- ECOG performance status of 0 to 1 (or 0 to 2)
- At least one measurable tumor lesion by RECIST 1.1 criteria
- Adequate organ function within protocol-defined limits
- Willingness to have blood drawn and undergo required biopsies when medically feasible
- Negative pregnancy test for participants who can become pregnant and agreement to effective contraception during and after treatment
You will not qualify if you...
- Prior gene-modified cellular therapy (e.g., CAR-T or CAR-NK) within the required washout period
- Active, uncontrolled infection needing intravenous antibiotics
- Known uncontrolled HIV infection
- Active hepatitis B or C infection with detectable viral load
- Active central nervous system 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 limits
- Significant cardiovascular disease such as recent heart attack or unstable arrhythmia
- Uncontrolled pulmonary disease or other serious comorbid conditions increasing risk
- Recent major surgery or anticancer therapy too close to lymphodepletion (per protocol washout requirements)
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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