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NCT06803875 · ClinicalTrials.gov registry record · Phase 1
Study of hALK.CAR T Cells for Patients With Relapsed/Refractory High-risk Neuroblastoma
A Phase 1 study of High-risk Neuroblastoma and Refractory Neuroblastoma, sponsored by Roberto Chiarle.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 2
- Study locations
NCT06803875: Recruiting Phase 1 study of High-risk Neuroblastoma and Refractory Neuroblastoma, sponsored by Roberto Chiarle.
NCT06803875 is a Phase 1 study of High-risk Neuroblastoma and Refractory Neuroblastoma that is actively recruiting participants, run by Roberto Chiarle. The registered enrollment target is 42 participants, below the 61-participant average among 9 other High-risk Neuroblastoma trials with a reported enrollment target (31% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06803875, a Phase 1 study of High-risk Neuroblastoma and Refractory Neuroblastoma, is actively recruiting participants, sponsored by Roberto Chiarle.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Autologous hALK.CAR T cells
Study Locations (2)
Massachusetts
- Boston Children's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2025-01-31 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 1 |
What NCT06803875 shows while recruiting
NCT06803875 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 61-participant average among 9 other High-risk Neuroblastoma trials with a reported enrollment target (31% lower).
The record links to 3 conditions, with High-risk Neuroblastoma appearing as the primary indexed condition, and to 1 intervention - of which Autologous hALK.CAR T cells is the first listed.
NCT06803875 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06803875 about?
NCT06803875 is a clinical study titled "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 i...
What is the current status of trial NCT06803875?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2025-01-31. Estimated completion is 2029-12-31.
What conditions does trial NCT06803875 study?
This clinical trial studies the following conditions: High-risk Neuroblastoma, Refractory Neuroblastoma, Relapsed Neuroblastoma.
What interventions are being tested in trial NCT06803875?
The interventions under investigation include: Autologous hALK.CAR T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT06803875?
This trial is sponsored by Roberto Chiarle, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06803875 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for High-risk Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06803875's enrollment target sits among peer trials
42 8th of 9 higher than 1 of 9 other High-risk Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High-risk Neuroblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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