Status: Recruiting
Study of hALK.CAR T Cells for Patients With Relapsed/Refractory High-risk Neuroblastoma
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 will be an expansion phase to determine rates of response to hALK.CAR T cells.
Participants needed: 42
Trial details
Phase: Phase 1, Phase 2Age: 12-29Biological sex: AllType: InterventionalSponsor: Roberto ChiarleUpdated: Dec 26, 2025Locations: 2
Eligibility criteria
Age ≥ 12 months and < 30 years at the time of consent. The first patient on each... [+9]
Pregnant or nursing (lactating) women [+12]