Study of hALK.CAR T Cells for Patients With Relapsed/Refractory High-risk Neuroblastoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-29
SponsorRoberto Chiarle
About this trial
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 criteria
Qualifiers
Age ≥ 12 months and < 30 years at the time of consent. The first patient on each dose level will need to be age ≥ 6 years old
Patients must have histologic verification of neuroblastoma at diagnosis or at relapse
Patients must have high-risk neuroblastoma according to Children's Oncology Group (COG) risk classification at time of study enrollment
Patients must have persistent/refractory or relapsed disease for which standard curative measures are no longer effective, as defined in the protocol
Disqualifiers
Pregnant or nursing (lactating) women
Patients with uncontrolled active infection
Patients who are concurrently receiving other investigational agents
Patients who have received prior CART-cell or other gene-modified immune-effector cell therapy, are not eligible unless they are >8 weeks from time of infusion, have fully recovered from any associated toxicities and have documented lack of persistence of the product
Trial design
Treatments tested in this trial
- Autologous hALK.CAR T cells
Treatment groups
42 Participants
are divided into 1 treatment groupSponsors and collaborators
Roberto Chiarle
Lead sponsor
Boston Children's Hospital
Sponsor institution
Boston Children's Hospital
Collaborator
Dana-Farber Cancer Institute
Collaborator
Source ClinicalTrials.gov