Actively Recruiting
A Phase 1/2, Open-Label, Biomarker-Driven Study of Allogeneic Donor-Derived CAR-NK Cells With Antigen Selection by Tissue Biopsy and/or Liquid Biopsy Profiling in Participants With Relapsed/Refractory Advanced Solid Tumors (Single-Target vs Dual-Target Strategy)
Led by Essen Biotech · Updated on 2026-02-18
85
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and early anti-tumor effects of allogeneic donor-derived CAR-NK cells in people with advanced solid tumors that have returned or do not respond to standard treatments. The study uses a biomarker-driven approach, where tumor profiling through tissue or liquid biopsy helps select the target antigen or antigens for each participant's treatment. This open-label Phase 1/2 trial compares single-target and dual-target CAR-NK cell therapies based on the tumor antigen profile. Participants undergo tumor antigen profiling to determine eligibility and whether they receive a single-target or dual-target CAR-NK cell product. CAR-NK cells are collected from healthy donors, genetically modified to express one or two chimeric antigen receptors, and given after lymphodepleting chemotherapy with drugs like fludarabine and cyclophosphamide. Optional low-dose interleukin-2 may be given to support the CAR-NK cells. The study includes arms for single-target and dual-target antigen therapies based on the participant's tumor profile. During the study, participants have safety monitored intensively for 28 days after treatment. Tumor imaging and correlative studies, including CAR-NK cell persistence and circulating tumor DNA levels, are performed at scheduled times. Researchers track adverse events and dose-limiting toxicities in the first month and evaluate tumor response and disease control over 12 months. Participants will also undergo blood draws and biopsies as needed. The total study duration varies by participant and includes follow-up assessments to understand treatment effects and safety.
CONDITIONS
Brief 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 18-75 years
- Confirmed advanced, unresectable, or metastatic solid tumor that is relapsed or refractory after standard therapy or with no standard therapy available
- Positive target antigen from tissue biopsy and/or liquid biopsy as defined by the study
- ECOG performance status of 0-1 or 0-2
- At least one measurable tumor lesion by RECIST 1.1 criteria
- Adequate organ function (blood, kidney, liver, heart) within study limits
- Willingness to undergo blood draws and biopsies when medically feasible
- Negative pregnancy test for those who can become pregnant and agreement to use effective contraception during and after treatment
You will not qualify if you...
- Prior treatment with gene-modified cellular therapy such as CAR-T or CAR-NK within a defined washout period
- Active, uncontrolled infection requiring intravenous antibiotics
- Known uncontrolled HIV infection
- Active hepatitis B or C infection with detectable viral load
- Active central nervous system metastases requiring increasing steroids or urgent treatment (stable treated CNS disease may be allowed)
- Active autoimmune disease needing systemic immunosuppression or chronic systemic steroids above protocol limits
- Significant heart disease (e.g., recent heart attack, unstable arrhythmia), uncontrolled lung disease, or other serious health conditions increasing risk
- Recent major surgery or anticancer therapy too close to lymphodepletion chemotherapy
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 28 days
Participants receive lymphodepleting chemotherapy followed by infusion of allogeneic donor-derived CAR-NK cells targeting one or two antigens based on tumor profiling. Optional cytokine support may be given to support NK cell persistence.
Multiple visits during conditioning and infusion period
Duration - Up to 12 months
Participants undergo intensive safety monitoring for 28 days after treatment and have tumor imaging and correlative studies performed at protocol-defined intervals.
Regular imaging and safety visits throughout follow-up
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
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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