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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Roberto Chiarle
Study ID
NCT06803875
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Months - 29 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous hALK.CAR T cells — BIOLOGICAL
    Autologous chimeric antigen receptor T cells targeting the human Anaplastic Lymphoma Kinase (ALK) receptor

Study Details

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.

Key Dates

Start date
Jan 31, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Dose Escalation
    The dose escalation arm will determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of hALK.CAR T cells using a standard 3+3 dose escalation design.

Primary Outcome Measure

Phase 1: Determine the Maximum Tolerated Dose (MTD) of hALK.CAR T cells [ Time Frame: 5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Susanne Baumeister, MD
[email protected]
617-632-3796
Susanne Baumeister, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02115
Susanne Baumeister, MD
[email protected]
617-632-3796
Susanne Baumeister, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Boston Children's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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