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New treatment option for Relapsed Neuroblastoma
Official title Study of hALK.CAR T Cells for Patients With Relapsed/Refractory High-risk Neuroblastoma
ClinicalTrials.gov ID: NCT06803875
What this study is testing
What is Autologous hALK.CAR T cells?
Autologous hALK.CAR T cells is an investigational medicine, being studied as a potential treatment for relapsed 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
- This Phase 1/2 trial aims to determine the safety and feasibility of administration of autologous chimeric antigen receptor (CAR) T cells targeting the human Anaplastic Lymphoma Kinase (ALK) receptor in pediatric subjects with relapsed or refractory neuroblastoma (NB). The trial will be conducted in two phases: Phase 1 will determine the maximum tolerated dose (MTD) of autologous hALK.CAR T cells using a 3+3 dose escalation design.
- 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 12 to 29
You may be able to join if
- Age ≥ 12 months and \< 30 years at the time of consent. The first patient on each dose level will need to be age ≥ 6 years old
- Disease Status:
- Patients must have histologic verification of neuroblastoma at diagnosis or at relapse
- Patients must have high-risk neuroblastoma according to Children's Oncology Group (COG) risk classification at time of study enrollment
- Patients must have persistent/refractory or relapsed disease for which standard curative measures are no longer effective, as defined in the protocol
You likely can't join if
- Pregnant or nursing (lactating) women
- Patients with uncontrolled active infection
- Patients who are concurrently receiving other investigational agents
- Patients who have received prior CART-cell or other gene-modified immune-effector cell therapy, are not eligible unless they are \>8 weeks from time...
- Patients with a known additional malignancy other than non-melanomatous skin cancer or carcinoma in situ, unless not requiring active treatment and...
- Uncontrolled CNS metastasis
See the full eligibility criteria
- Age ≥ 12 months and \< 30 years at the time of consent. The first patient on each dose level will need to be age ≥ 6 years old
- Disease Status:
- Patients must have histologic verification of neuroblastoma at diagnosis or at relapse
- Patients must have high-risk neuroblastoma according to Children's Oncology Group (COG) risk classification at time of study enrollment
- Patients must have persistent/refractory or relapsed disease for which standard curative measures are no longer effective, as defined in the protocol
- Patients must have evaluable or measurable disease per the revised International Neuroblastoma Response Criteria (INRC)
- Adequate washout from prior treatment regimens
- Adequate organ function
- Adequate performance status defined as Lansky or Karnofsky performance score ≥50%
- people of reproductive potential must agree to use acceptable birth control methods
- Signed informed consent
- Pregnant or nursing (lactating) women
- Patients with uncontrolled active infection
- Patients who are concurrently receiving other investigational agents
- Patients who have received prior CART-cell or other gene-modified immune-effector cell therapy, are not eligible unless they are \>8 weeks from time of infusion, have fully recovered from any associated toxicities and...
- Patients with a known additional malignancy other than non-melanomatous skin cancer or carcinoma in situ, unless not requiring active treatment and stable or disease-free for at least 3 years
- Uncontrolled CNS metastasis
- CNS disorder such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement which may impair the ability to evaluate neurotoxicity
- History of severe hypersensitivity reaction to compounds used in the study
- HIV/HBV/HCV infection
- Patients receiving systemic steroid therapy (physiologic replacement, inhaled steroids and premedication for blood products are allowed)
- Primary immunodeficiency or history of systemic autoimmune disease requiring systemic immunosuppression/disease modifying agents within the last 2 years
- Uncontrolled intercurrent illness
- Inability to comply with the study requirements
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
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, 12 months to 29 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. 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.