Phase 1 Trial of GPC2-Directed Chimeric Antigen Receptor Autologous T Cells (GPC2 CAR T) for Relapsed or Refractory Neuroblastoma

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: f
View:

• Signed Informed Consent Form

• ≥ 1 year of age

• Disease status

‣ Patients must have high-risk neuroblastoma according to Children's Oncology Group risk classification at the time of study enrollment.

⁃ Histologically confirmed diagnosis of neuroblastoma that is recurrent/relapsed/persistent according to International Neuroblastoma Response Criteria

⁃ Patients must have evaluable or measurable disease at enrollment

• Adequate organ function

• Adequate performance status defined as Lanksy or Karnofsky performance score ≥60.

• Subjects of reproductive potential must agree to use acceptable birth control methods.

Locations
United States
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Melissa Varghese
Varghesem@chop.edu
8455535358
Backup
Yael Mosse, MD
mosse@chop.edu
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2030-01-30
Participants
Target number of participants: 30
Treatments
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.
Sponsors
Leads: Stephan Grupp MD PhD
Collaborators: Children's Hospital of Philadelphia, Gilead Sciences, National Cancer Institute (NCI), University of Pennsylvania

This content was sourced from clinicaltrials.gov