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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06803875
The ClinicalTrials.gov registry entry for NCT06803875 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61-participant average among 9 other High-risk Neuroblastoma trials with a reported enrollment target (31% lower). The listed sponsor is Roberto Chiarle, which has 1 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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