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Tests treatment safety and results for Neuroblastoma (NB)
Official title Safety and Efficacy of CAR-T Cell Therapy for Relapsed/refractory Neuroblastoma and Desmoplastic Small Round Cell Tumors: a Single-arm, Open-label Trial.
ClinicalTrials.gov ID: NCT06836505
What this study is testing
What is CART therapy?
CART therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuroblastoma (nb).
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
- Title: Safety and efficacy of CAR-T cell therapy for relapsed/refractory neuroblastoma and desmoplastic small round cell tumors: a single-arm, open-label trial. The CART used in this study will be provided by Shanghai YaKe Biotechnology Ltd.
- Phase 2: a mid-size study of how well it works
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 50
You may be able to join if
- Patients who are diagnosed as relapsed/refractory neuroblastoma or relapsed/refractory desmoplastic small round cell tumors;
- Age 1-50 years, any gender;
- Agree to participate in the trial and sign a written informed consent form;
- Expected survival of ≥12 weeks;
- Karnofsky performance status (for patients ≥16 years) or Lansky performance status (for patients \<16 years) (Appendix 1) must be at least 50;
You likely can't join if
- Patients with any of the following items will not be enrolled in this study:
- Patients with increased intracranial pressure or altered consciousness;
- Patients who have received radiation therapy within 2 weeks prior to infusion;
- Patients with active hepatitis B (defined as HBV DNA \> 500 IU/mL) or hepatitis C (HCV RNA positive);
- HIV-positive patients or patients with a positive syphilis test;
- Patients with uncontrolled acute life-threatening bacterial, viral, or fungal infections (e.g., positive blood cultures within ≤72 hours before...
See the full eligibility criteria
- Patients who are diagnosed as relapsed/refractory neuroblastoma or relapsed/refractory desmoplastic small round cell tumors;
- Age 1-50 years, any gender;
- Agree to participate in the trial and sign a written informed consent form;
- Expected survival of ≥12 weeks;
- Karnofsky performance status (for patients ≥16 years) or Lansky performance status (for patients \<16 years) (Appendix 1) must be at least 50;
- Good function of major organs:
- Liver function: ALT ≤ 5 times the upper limit of normal for the corresponding age, and bilirubin ≤ 2.0 mg/dL, except for patients with Gilbert-Meulengracht syndrome. Patients with Gilbert-Meulengracht syndrome who have...
- Renal function: Plasma creatinine ≤ 1.5 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m²;
- Pulmonary function: Oxygen saturation ≥ 95% in room air;
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 45%;
- Patients using the following medications must meet the following conditions: Steroids: Steroid treatment doses must be stopped at least 2 weeks before CAR-T infusion. However, physiological replacement doses of steroids...
- Patients of childbearing potential (both male and female) must agree to use reliable contraception methods (hormonal or barrier methods or abstinence) with their partner until at least 12 months after CAR-T cell...
- If the subject cannot provide suitable T cells for CAR-T preparation, T cells from a healthy donor may be collected for preparation.
- Patients with any of the following items will not be enrolled in this study:
- Patients with increased intracranial pressure or altered consciousness;
- Patients who have received radiation therapy within 2 weeks prior to infusion;
- Patients with active hepatitis B (defined as HBV DNA \> 500 IU/mL) or hepatitis C (HCV RNA positive);
- HIV-positive patients or patients with a positive syphilis test;
- Patients with uncontrolled acute life-threatening bacterial, viral, or fungal infections (e.g., positive blood cultures within ≤72 hours before infusion);
- Patients with unstable angina and/or myocardial infarction within 6 months prior to screening;
- Patients with a history of or concurrent malignancies, except for the following conditions:
- Basal cell carcinoma or squamous cell carcinoma that has been adequately treated (sufficient wound healing required before study enrollment);
- Carcinoma in situ of the cervix or breast that has been cured, with no signs of recurrence for at least 3 years before the study;
- Primary malignant tumors that have been completely resected and have been in complete remission for ≥5 years;
- Pregnant or breastfeeding female patients;
- Patients with uncontrolled arrhythmias that have not been managed medically;
- Patients who need oral anticoagulation therapy within 1 week before CAR-T cell infusion;
- Patients with active neuroautoimmune or inflammatory diseases (e.g., Guillain-Barré syndrome, amyotrophic lateral sclerosis);
- Other conditions deemed inappropriate for participation in the clinical study by the investigator. Patients enrolled in the clinical study must meet the inclusion criteria and not meet the exclusion criteria.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Dongguan, Guang, China
- Shanghai, Shanghai Municipality, 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 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Dongguan, Guang, China; Shanghai, Shanghai Municipality, 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.