hALK.CAR T Cells for Relapsed/Refractory High-risk Neuroblastoma
This study is testing a new treatment called hALK.CAR T cells for children and young adults with high-risk neuroblastoma that has come back (relapsed) or is not responding to other treatments (refractory). hALK.CAR T cells are a type of cell therapy where your own immune cells are specially trained to find and fight cancer cells that have a specific marker called ALK. The study aims to find the safest and most effective dose of hALK.CAR T cells and see how well they work in shrinking tumors. You may be eligible if you are between 12 months and 29 years old and have high-risk neuroblastoma that has been confirmed by a biopsy. The study plans to enroll 42 participants.
- Study design
- This is an interventional Phase 1/2 study, meaning it tests a new treatment. It will enroll 42 participants and is designed in two parts: first to find the best dose, then to see how well the treatment works.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for up to 5 years to measure the maximum tolerated dose, manufacturing feasibility, and response rates.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of hALK.CAR T Cells for Patients With Relapsed/Refractory High-risk Neuroblastoma
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Susanne Baumeister, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
Who to contact
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What this trial measures
- Phase 1: Determine the Maximum Tolerated Dose (MTD) of hALK.CAR T cells5 years
The Maximum Tolerated Dose (MTD) of hALK.CAR T cells will be determined by measuring the incidence of dose limiting toxicities (DLT) following administration of the hALK.CAR T cell product using a 3+3 dose escalation design.
- Phase 1: Evaluate Manufacturing Feasibility of hALK.CAR T cells5 years
Manufacturing feasibility will be evaluated as the proportion of patients undergoing leukapheresis who achieve manufacturing of a hALK.CAR T cell product that meets release criteria.
- Phase 2: Estimate Response RatesUp to 5 years
The complete response (CR) and partial response (PR) rates per revised International Neuroblastoma Response Criteria (INRC) of subjects with relapsed or refractory high-risk neuroblastoma who are treated with hALK.CAR T cells will be estimated.