Actively Recruiting
Dual-Target GD2/B7-H3 CAR-NK Cells for Pediatric Relapsed or Refractory Neuroblastoma
Led by Beijing Biotech · Updated on 2026-03-30
36
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This illustrative Phase 1/Phase 2 study tests allogeneic dual-target GD2/B7-H3 (CD276) CAR-NK cells in children and young adults with relapsed or refractory neuroblastoma. After lymphodepletion, participants receive IV CAR-NK cells;Part A defines the RP2D and Part B estimates preliminary activity
CONDITIONS
Official Title
Dual-Target GD2/B7-H3 CAR-NK Cells for Pediatric Relapsed or Refractory Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 months to 21 years at consent/assent
- Histologically confirmed neuroblastoma or ganglioneuroblastoma with relapsed, refractory, progressive, or persistent high-risk disease without curative standard options
- Measurable or evaluable disease by revised International Neuroblastoma Response Criteria, including MIBG-avid, CT/MRI soft-tissue, or bone marrow disease
- Available tumor material for central testing showing at least one positive target (GD2 or B7-H3)
- Prior exposure to standard neuroblastoma therapy, including anti-GD2 therapy, unless contraindicated or declined for medical reasons
- Lansky or Karnofsky performance score of 50 or higher
- Life expectancy of at least 8 weeks
- Recovery from significant acute toxicities of prior treatments and required washout from chemotherapy, biologics, radiation, and prior cell therapy
- Adequate hematologic, renal, hepatic, cardiac, and pulmonary function per protocol
- Negative pregnancy test for those of childbearing potential and agreement to use effective contraception during the study
- Written informed consent from parent/legal guardian and participant assent when appropriate
You will not qualify if you...
- Active uncontrolled infections including bacteremia, viral infection, or invasive fungal disease
- Pregnancy or breastfeeding
- Active grade 2 or higher graft-versus-host disease or recent systemic immunosuppression after prior allogeneic transplant
- Symptomatic or unstable central nervous system disease needing urgent intervention
- Prior genetically modified cell therapy within washout period or unresolved toxicity from prior cell therapy
- Active autoimmune disease requiring systemic immunosuppressive treatment
- Clinically significant uncontrolled cardiovascular, pulmonary, hepatic, renal, or neurologic disorders increasing study risk
- Known hypersensitivity to fludarabine, cyclophosphamide, study product components, or required supportive medications
- Known uncontrolled HIV infection or uncontrolled hepatitis B or C
- Any medical, psychosocial, or logistical condition judged by investigators to make participation unsafe or adherence difficult
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here