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Study identifier: NCT06803875 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Study of hALK.CAR T Cells for Patients With Relapsed/Refractory High-risk Neuroblastoma

Condition: Relapsed Neuroblastoma · Refractory Neuroblastoma · High-risk Neuroblastoma  ·  Sponsor: Roberto Chiarle

PhasePhase 1/Phase 2
Planned participants42
Who can joinAll sexes, 12 Months to 29 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Susanne Baumeister, MD  ·  617-632-3796  ·  dfbchpedicelltherapy@dfci.harvard.edu

Audra Caine  ·  617-632-3796  ·  audra_caine@dfci.harvard.edu

Always discuss trial participation with your own doctor first.

Locations (2)

Boston Children's HospitalBoston, Massachusetts, United StatesRecruiting
Dana-Farber Cancer InstituteBoston, Massachusetts, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06803875