Actively Recruiting
A Study on the Efficacy of GD2-CAR T Cells in the Treatment of Neuroblastoma
Led by The General Hospital of Western Theater Command · Updated on 2024-12-20
30
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
Sponsors
T
The General Hospital of Western Theater Command
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Neuroblastoma (NB) is a malignant tumor of the sympathetic nervous system.Chemotherapy and autologous hematopoietic stem cell transplantation are the main treatments for neuroblastoma, and the prognosis of patients with high-risk recurrence and refractory treatment is very poor. There is a large unmet medical need in patients with relapsed refractory neuroblastoma, and further research into new therapeutic approaches is needed for these patients.GD2 is a dissialic ganglioside expressed by neuroectodermal tumors. The proportion of GD2 expression in neuroblastoma is up to 100%, so GD2 is a specific target for neuroblastoma immunotherapy and an ideal target for CAR-T treatment of neuroblastoma.
CONDITIONS
Official Title
A Study on the Efficacy of GD2-CAR T Cells in the Treatment of Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed neuroblastoma with positive GD2 antigen expression in tumor cells
- Diagnosis of recurrent or refractory neuroblastoma
- At least 2 weeks or 5 half-lives (whichever is shorter) since starting preconditioning chemotherapy after prior treatment
- Toxic reactions from previous therapy stabilized to grade 1 or less
- Age over 1 year and under 18 years
- Physical strength score between 0 and 3 (ECOG standard)
- No obvious active infection
- Expected survival of 3 months or more
- Adequate kidney, liver, lung, and heart function as specified
- Negative pregnancy test for fertile women; surgical sterilization or menopause for others
You will not qualify if you...
- Other malignancies unless disease-free for at least 3 years
- Uncontrollable infections of any type
- Known HIV infection
- Known hepatitis B or C infection unless viral tests are negative and monitored
- Existing or past central nervous system diseases
- Serious heart conditions or recent heart events
- Any medical condition affecting safety or efficacy evaluation
- Severe hypersensitivity to study drugs
- Live vaccine given within 6 weeks before pretreatment
- Pregnant or breastfeeding females
- Lack of consent to effective contraception during and after treatment
- Inability or unwillingness to comply with study visits and procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The General Hospital of Western Theater Command
Chengdu, Sichuan, China
Actively Recruiting
Research Team
J
JunXia Wang, Ph.D
CONTACT
H
Hai Yi, Ph.D
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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