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Tests treatment safety and results for Neuroblastoma
Official title A Study on the Efficacy of GD2-CAR T Cells in the Treatment of Neuroblastoma
ClinicalTrials.gov ID: NCT06684639
What this study is testing
What is GD2-CAR-T cell?
GD2-CAR-T cell is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuroblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- All cases were diagnosed as neuroblastoma with positive expression of GD2 antigen in tumor cells. Informed consent of patient or guardian.
- Diagnosis of recurrent/refractory neuroblastoma.
- At least 2 weeks or 5 half-lives (whichever is shorter) from the beginning of preconditioning chemotherapy after prior systemic treatment.
- Toxic reactions caused by previous antitumor therapy must be stabilized and restored to ≤ grade 1.
- Over 1 years old, under 18 years old.
You likely can't join if
- The subject has had other malignancies, non-melanoma skin tumors, carcinoma in situ (e.g. Cervix, bladder, breast), unless disease-free survival of...
- There is an uncontrollable infection, including fungal, bacterial, viral or other.
- Known human immunodeficiency virus (HIV) infection.
- Known history of hepatitis B (HBsAg positive) or hepatitis C (HCV antibody positive). people with latent or prehepatitis B infection (defined as...
- Existing or past CNS disease, such as seizures, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any CNS-related autoimmune...
- Serious heart disease, such as uncontrolled or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months prior to...
See the full eligibility criteria
- All cases were diagnosed as neuroblastoma with positive expression of GD2 antigen in tumor cells. Informed consent of patient or guardian.
- Diagnosis of recurrent/refractory neuroblastoma.
- At least 2 weeks or 5 half-lives (whichever is shorter) from the beginning of preconditioning chemotherapy after prior systemic treatment.
- Toxic reactions caused by previous antitumor therapy must be stabilized and restored to ≤ grade 1.
- Over 1 years old, under 18 years old.
- Physical strength score 0-3 (ECOG standard).
- No obvious active infection.
- Expected survival ≥3 months
- Adequate kidney, liver, lung and heart function, defined as creatinine clearance (estimated by the Cockcroft Gault formula) \> 60 mL/min; Serum ALT/AST ≤ 2.5 ULN; Total bilirubin ≤1.5 ULN, excluding people with...
- The serum pregnancy test results of fertile women must be negative (women who have undergone surgical sterilization or at least 2 years after menopause are considered to be infertile).
- The subject has had other malignancies, non-melanoma skin tumors, carcinoma in situ (e.g. Cervix, bladder, breast), unless disease-free survival of at least 3 years.
- There is an uncontrollable infection, including fungal, bacterial, viral or other.
- Known human immunodeficiency virus (HIV) infection.
- Known history of hepatitis B (HBsAg positive) or hepatitis C (HCV antibody positive). people with latent or prehepatitis B infection (defined as HBcAb positive and HBsAg negative) can be enrolled only if PCR tests for...
- Existing or past CNS disease, such as seizures, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any CNS-related autoimmune disease.
- Serious heart disease, such as uncontrolled or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months prior to screening, or any grade 3 (moderate) or 4 (severe) heart disease...
- A history of myocardial infarction, angioplasty or stent placement, unstable angina pectoris, or other clinically significant heart disease in the 12 months prior to enrollment.
- Any medical condition that may affect the evaluation of safety or how well it works.
- Have had severe rapid hypersensitivity reactions to any of the drugs to be used in this study.
- Live vaccine should be administered within ≤6 weeks before starting the pretreatment regimen.
- Pregnant or lactating female people.
- Male or female people who do not consent to effective contraception from the time they sign informed consent until 6 months after completing immune cell therapy.
- people judged by the investigator had difficulty in completing all visits or procedures required by the study protocol (including follow-up visits), or were not compliant enough to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.