GPC2 CAR T Cells for Relapsed or Refractory Neuroblastoma and Metastatic Retinoblastoma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Stephan Grupp MD PhD
Study ID
NCT05650749
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • GPC2 CAR T cells — BIOLOGICAL
    The GPC2 CAR T investigational product is comprised of autologous human T cells that have been genetically modified to express a GPC2-targeting chimeric antigen receptor (CAR) transgene.

Study Details

This is a first in human dose escalation trial to determine the safety of administering GPC2 CAR T cells in patients with advanced neuroblastoma or retinoblastoma.

Key Dates

Start date
May 23, 2023
Status verified
Dec 2025
Primary completion
Jan 30, 2028
Completion
Jan 30, 2030

Study Design

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

Arms

  • Experimental: Dose Escalation Arm
    The dose escalation arm will determine the maximum tolerated dose of GPC2 CAR T cells using a standard 3+3 trial design.
  • Experimental: Dose Expansion Arm
    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 GPC2 CAR T cells and further characterize the safety profile of GPC2 CAR T cells.

Primary Outcome Measure

Determine the Maximum Tolerated Dose of GPC2 CAR T cells [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
CART Nurse Navigator
[email protected]
445-942-5891
Melissa Varghese, M.S.
[email protected]
845-553-5358
Lisa Wray, 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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