Actively Recruiting
Chimeric Natural Killer Receptor-Universal T Cells for Relapsed or Refractory Neuroblastoma
Led by Nanjing Children's Hospital · Updated on 2025-02-07
12
Participants Needed
2
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, preliminary efficacy, pharmacokinetics of universal T-cells engineered with chimeric natural killer receptor (CNK-UT) to treat the patients with relapsed/refractory Neuroblastoma.
CONDITIONS
Official Title
Chimeric Natural Killer Receptor-Universal T Cells for Relapsed or Refractory Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 1-12 years with weight 6510 kg, male or female
- Child and/or guardian has signed informed consent and can follow study rules
- Diagnosed with relapsed or refractory neuroblastoma as defined by NCCN guidelines
- Disease status before enrollment is partial remission or stable disease
- At least one measurable lesion via imaging or bone marrow exam, with target lesion 642 cm if soft tissue
- Tumor tissue confirmed positive for B7-H3 protein by immunohistochemistry
- Lansky performance score greater than 60
- Estimated life expectancy over 12 weeks
- Adequate organ and bone marrow function based on lab tests within 7 days before enrollment
- Toxic effects from prior treatments resolved to mild or none except hair loss
You will not qualify if you...
- Having other malignant tumors diagnosed within 5 years, except some skin, thyroid, or breast cancers
- Symptomatic central nervous system metastases confirmed by imaging or pathology
- MIBG non-avid disease
- History of organ transplant excluding stem cell transplant
- Active autoimmune diseases needing systemic treatment, or known primary immunodeficiency
- Uncontrolled systemic diseases or metabolic disorders increasing medical risk
- Active tuberculosis, HIV infection, or syphilis
- Severe infections or hospitalizations due to infection within 4 weeks prior
- Recent radiotherapy, chemotherapy (excluding lymphodepletion), targeted or immune therapies within 4 weeks
- Major surgery within 4 weeks or severe unhealed wounds
- Participation in other clinical trials within 4 weeks
- Use of attenuated live vaccines within 4 weeks
- Previous gene therapy
- Allergy to CNK-UT injection components
- Mental or substance abuse disorders interfering with study compliance
- Other serious complications or conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Nanjing Children's Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
2
Nanjing
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
F
Fang Yongjun, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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