RecruitingPhase 1Phase 2NCT06803875

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

A Phase 1/2 Study of hALK.CAR T Cells for Patients With Relapsed/Refractory High-risk Neuroblastoma


Sponsor

Roberto Chiarle

Enrollment

42 participants

Start Date

Jan 31, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 MonthsMax Age: 29 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called hALK.CAR T cells for children and young adults with high-risk neuroblastoma — a type of cancer that usually starts in the adrenal glands — that has come back or stopped responding to standard treatment. **You may be eligible if...** - You are between 12 months and 30 years old (first patients on each dose must be at least 6 years old) - You have been confirmed to have high-risk neuroblastoma that has relapsed or is no longer responding to standard treatments - You have measurable disease that can be tracked - Your organs are functioning well enough to tolerate treatment - You are physically able to participate (able to perform at least some normal activities) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have an active uncontrolled infection - You are currently in another experimental treatment trial - You have received a similar cell therapy recently (within the past 8 weeks) - You have HIV, hepatitis B, or hepatitis C infection - You are currently taking systemic steroid medications - You have a serious autoimmune disease requiring immune-suppressing drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALAutologous hALK.CAR T cells

Autologous chimeric antigen receptor T cells targeting the human Anaplastic Lymphoma Kinase (ALK) receptor


Locations(2)

Boston Children's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06803875


Related Trials