Actively Recruiting
TAA06 Injection in the Treatment of Patients With B7-H3-positive Relapsed/ Refractory Neuroblastoma
Led by PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Updated on 2023-02-27
24
Participants Needed
2
Research Sites
842 weeks
Total Duration
On this page
Sponsors
P
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Lead Sponsor
T
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase I clinical trials are designed as open-label, dose-escalation and dose-expansion clinical studies, the main purpose of which is to explore the tolerability, safety, cytokinetic characteristics and RP2D and preliminary observation of the efficacy of the study drug in subjects with B7-H3-positive relapsed/refractory neuroblastoma.
CONDITIONS
Official Title
TAA06 Injection in the Treatment of Patients With B7-H3-positive Relapsed/ Refractory Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1 year or older, any gender
- Expected survival time of at least 3 months
- Karnofsky score above 60 (for those older than 16) or Lansky score above 60 (for those 16 or younger)
- Diagnosed with relapsed or refractory neuroblastoma following standard treatments
- Tumor tissue shows B7-H3 expression at 1+ intensity or higher on at least 1% of tumor cells
- At least one measurable tumor lesion per RECISTv1.1, with at least one lesion suitable for radiation (except bone marrow)
- Patients with only bone marrow lesions are eligible without radiation
- Liver and kidney function within defined limits (bilirubin ≤3× upper limit, ALT and AST ≤5× upper limit, creatinine ≤2× upper limit)
- Heart function with left ventricular ejection fraction ≥50%
- Blood oxygen saturation ≥92%
- Patients and/or guardians understand the trial and have signed informed consent
You will not qualify if you...
- Need for long-term immunosuppressive therapy at screening
- Stroke or seizure within 6 months before consent
- Other malignant tumors except carcinoma in situ
- Positive for hepatitis B surface antigen or abnormal hepatitis B core antibody with high HBV DNA
- Positive for hepatitis C antibody with detectable HCV RNA
- Positive for HIV antibody, CMV DNA, or syphilis
- Serious heart disease including recent heart attack, unstable angina, severe heart failure, or serious arrhythmia
- Unstable systemic diseases requiring medication, including severe liver, kidney, or metabolic diseases
- Chronic progressive neurological diseases
- Unrecovered acute toxic effects from previous treatments
- Active or uncontrolled infections needing systemic treatment (except mild urogenital or upper respiratory infections)
- Females planning pregnancy within 2 years of treatment or males with partners planning pregnancy within 2 years
- Previous CAR-T or gene-modified cell therapy
- Participation in other clinical trials within 1 month before screening
- Evidence of central nervous system involvement
- Liver metastases involving more than half the liver
- Investigator judgment that cell preparation is unsuitable
- Other investigator-determined reasons making participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250000
Not Yet Recruiting
2
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
H
HuiMin Meng, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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