PHOX2B PC-CAR T Cells for Relapsed Neuroblastoma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Stephan Grupp MD PhD
Study ID
NCT07007117
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • PHOX2B PC-CAR T Cells — BIOLOGICAL
    The PHOX2B PC-CAR T cell investigational product is comprised of autologous human T cells that have been genetically modified to express a a PHOX2B-targeting chimeric antigen receptor (CAR) transgene.

Study Details

This is a first in human dose escalation trial to determine the safety of administering PHOX2B PC-CAR T cells in patients with advanced, high-risk neuroblastoma.

Key Dates

Start date
Jun 20, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2032
Completion
Jun 30, 2035

Study Design

Enrollment
38 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    The dose escalation arm will determine the maximum tolerated dose of PHOX2B PC-CAR T cells using a standard 3+3 trial design.
  • Experimental: Dose Expansion
    If at least one dose from the dose expansion arm is determined to be safe, additional patients will be enrolled to the dose expansion arm to preliminarily evaluate the rate of response to PHOX2B-PC CAR T cells and further characterize the safety profile of PHOX2B-PC CAR T Cells

Primary Outcome Measure

Determine the Maximum Tolerated Dose of PHOX2B PC-CAR T Cells [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Allison Rocchi, RN, BSN
[email protected]
267-760-2874
CART Intake
[email protected]
445-942-5891
Jacquelyn Crane, MD (PRINCIPAL_INVESTIGATOR)
Yael Mosse, MD (SUB_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Children's Hospital of Philadelphia· Philadelphia, PA

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