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Clinical trialNCT06803875RecruitingPhase 1/PHASE2Interventional

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

SponsorRoberto ChiarleEnrollment42High-risk NeuroblastomaRefractory NeuroblastomaRelapsed Neuroblastoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Boston Children'S Hospital

    Boston, Massachusetts, United States

    Susanne Baumeister, MD
    Recruiting
  • Dana-Farber Cancer Institute

    Boston, Massachusetts, United States

    Susanne Baumeister, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Autologous hALK.CAR T cells
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jan 2025
Primary completion
31 Dec 2027
Completion
31 Dec 2029
Last update posted
26 Dec 2025
Registered enrollment
42
Registry id
NCT06803875
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.