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New treatment option for Neuroblastoma, Recurrent, Refractory
Official title Chimeric Natural Killer Receptor-Universal T Cells for Relapsed or Refractory Neuroblastoma
ClinicalTrials.gov ID: NCT06751134
What this study is testing
What is Chimeric Natural Killer Receptor Universal T-cells (CNK-UT)?
Chimeric Natural Killer Receptor Universal T-cells (CNK-UT) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuroblastoma, recurrent, refractory.
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
- 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.
- 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 12
You may be able to join if
- Aged 1-12 years with weight≥10kg, male or female;
- The child and/or guardian has signed the informed consent form (ICF) and has the ability to comply with the study requirements.
- Diagnosed with relapsed/refractory neuroblastoma. Clinical diagnostic criteria and first-line standard treatment can refer to the NCCN guidelines:
- Relapsed neuroblastoma: New lesions appear at the primary site or other locations 4 weeks after achieving complete remission through first-line...
- Refractory neuroblastoma: Failure to achieve complete remission after standard treatment protocols, which include induction chemotherapy, surgery...
You likely can't join if
- Suffering from malignant tumors or diagnosed within 5 years before enrollment, excluding radical skin basal cell carcinoma, skin squamous cell...
- Participants with symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination.
- Participants with MIBG non-avid disease.
- Participants with a history of organ transplantation（excluding stem cell transplantation）;
- Participants with active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or...
- Uncontrolled or irreparable systemic diseases, metabolic disorders, or other non-malignant organ diseases or cancer sequelae, which may lead to...
See the full eligibility criteria
- Aged 1-12 years with weight≥10kg, male or female;
- The child and/or guardian has signed the informed consent form (ICF) and has the ability to comply with the study requirements.
- Diagnosed with relapsed/refractory neuroblastoma. Clinical diagnostic criteria and first-line standard treatment can refer to the NCCN guidelines:
- Relapsed neuroblastoma: New lesions appear at the primary site or other locations 4 weeks after achieving complete remission through first-line standard treatment.
- Refractory neuroblastoma: Failure to achieve complete remission after standard treatment protocols, which include induction chemotherapy, surgery, and radiotherapy targeting the primary tumor and residual metastatic...
- Prior to enrollment, appropriate measures can be implemented to ensure that the subject's disease status is either partial remission (PR) or stable disease (SD).
- According to the INRC how well it works criteria, there must be at least one lesion whose how well it works can be assessed through functional imaging (123I-MIBG) and/or bone marrow examination (bone marrow aspiration...
- Tumor tissue sections or paraffin blocks can be provided, and it has been confirmed through immunohistochemistry (IHC) that the tumor tissue expresses B7-H3.
- Lansky score\>60；
- Estimated life expectancy \> 12 weeks;
- Adequate organ and bone marrow function, and the laboratory test value meets the following requirements within 7 days before enrollment, as follows: (1)Blood Routine Test: Absolute neutrophil...
- Suffering from malignant tumors or diagnosed within 5 years before enrollment, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, thyroid cancer, breast cancer (ductal carcinoma in situ) and / or...
- Participants with symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination.
- Participants with MIBG non-avid disease.
- Participants with a history of organ transplantation（excluding stem cell transplantation）;
- Participants with active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants) are considered. The use of replacement therapies (such as...
- Uncontrolled or irreparable systemic diseases, metabolic disorders, or other non-malignant organ diseases or cancer sequelae, which may lead to higher medical risks and/or uncertainties in survival assessment.
- Active pulmonary tuberculosis (TB), who is receiving anti-tuberculosis treatment or has received anti-tuberculosis treatment within 1 year before enrollment; human immunodeficiency virus (HIV) infection, known syphilis...
- Severe infections that are either active or poorly controlled clinically within 4 weeks prior to enrollment, including but not limited to hospitalization due to infections, bacteremia, or severe pneumonia complications...
- Received radiotherapy, chemotherapy (excluding lymphodepletion), molecular targeted therapy, immune checkpoint inhibitors, or other anti-tumor treatments within 4 weeks or 5 half-lives (whichever is shorter) before cell...
- Participants who have undergone major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the initiation of the study, or have severe unhealed wounds, ulcers, or fractures.
- Participants who have received treatment from other clinical trials within 4 weeks prior to the initiation of the study.
- Participants who receive attenuated live vaccines within 4 weeks prior to the initiation of the study.
- Participants who have used any gene therapy products prior to cell infusion.
- Allergic to components of CNK-UT injection.
- Participants suffer from known mental or substance abuse disorders, which may interfere with their ability to comply with research requirements.
- Participants considered by the investigator to have other potentially life-threatening serious complications that may interfere with the evaluation of this study..
- Other situations that the participant is identified by the investigator as unsuitable to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, 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 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, 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.