Study on HALK.CAR T Cells for Patients with Relapsed or Hard-to-Treat High-Risk Neuroblastoma

Sponsor: Roberto Chiarle

Sponsor score: 0

ClinicalTrials ID:NCT06803875

Provider View

This clinical trial is testing a new treatment using modified T cells to target a specific receptor in children and young adults with neuroblastoma that has returned or is not responding to standard treatments.

Patient Parameters

Program Overview

This study is exploring the safety and effectiveness of a new treatment using a patient's own T cells, which are modified to target the ALK receptor in neuroblastoma. The trial is divided into two phases: Phase 1 will find the safest dose of these modified T cells, and Phase 2 will see how well the treatment works in shrinking tumors in patients with relapsed or hard-to-treat neuroblastoma.

Description

The study is divided into two parts:

Phase 1:

  • The goal is to find the highest dose of modified T cells that patients can safely receive. This phase will also check if it's possible to make these modified T cells from patients' own cells.

Phase 2:

  • This phase will look at how well the treatment works by measuring the number of patients whose tumors completely or partially shrink after receiving the modified T cells.

The study is for children and young adults with high-risk neuroblastoma that has come back or is not responding to other treatments. Participants will receive the modified T cells and be monitored for safety and effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Age between 1 and 30 years old. The first patient at each dose level must be at least 6 years old.
  • Must have a confirmed diagnosis of neuroblastoma, either at the start or after a relapse.
  • Must have high-risk neuroblastoma according to specific medical guidelines.
  • The disease must be persistent or have returned after treatment, with no other effective standard treatments available.
  • Must have measurable disease according to specific criteria.
  • Must have had enough time since the last treatment to ensure safety.
  • Must have good organ function and a performance status score of 50% or higher.
  • Must agree to use birth control if of reproductive age.
  • Must provide signed informed consent.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Patients with uncontrolled active infections.
  • Patients currently receiving other experimental treatments.
  • Patients who have had previous CAR T-cell or similar therapies, unless it has been more than 8 weeks since the last treatment and they have recovered from any side effects.
  • Patients with another cancer, unless it is not requiring treatment and has been stable for at least 3 years.
  • Patients with uncontrolled cancer spread to the brain.
  • Patients with certain brain disorders that could affect the study.
  • Patients with severe allergies to study compounds.
  • Patients with HIV, hepatitis B, or hepatitis C infections.
  • Patients on systemic steroid therapy, except for specific allowed uses.
  • Patients with primary immune deficiencies or autoimmune diseases requiring treatment in the last 2 years.
  • Patients with uncontrolled other illnesses.
  • Patients unable to follow study requirements.

Locations

FACILITYZIPCITYSTATE
Boston Children's Hospital02115BostonMassachusetts
Dana-Farber Cancer Institute02115BostonMassachusetts

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