RECRUITING

GPC2 CAR T Cells for Relapsed or Refractory Neuroblastoma

Conditions

Refractory Neuroblastoma Relapsed Neuroblastoma High-risk Neuroblastoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-05-23

Study Completion:2026-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05650749

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Signed Informed Consent Form 2. ≥ 1 year of age 3. Disease status 1. Patients must have high-risk neuroblastoma according to Children's Oncology Group risk classification at the time of study enrollment. 2. Histologically confirmed diagnosis of neuroblastoma that is recurrent/relapsed/persistent according to International Neuroblastoma Response Criteria 3. Patients must have evaluable or measurable disease at enrollment 4. Adequate organ function 5. Adequate performance status defined as Lanksy or Karnofsky performance score ≥60. 6. Subjects of reproductive potential must agree to use acceptable birth control methods.	1. Patients with active hepatitis B or active hepatitis C. 2. Patients with HIV infection. 3. Patients with uncontrolled active infection 4. Patients with primary or acquired immunodeficiency disorder. 5. Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or immunosuppression during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well. 6. Patients with actively progressing Central Nervous System metastases, including parenchymal or leptomeningeal involvement. 7. Active medical disorder that, in the opinion of the investigator, would substantially increase. the risk of uncontrollable Cytokine Release Syndrome and/or neurotoxicity. 8. Patients with congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis. 9. Patients who have received any live vaccines within 30 days prior to enrollment. 10. Pregnant or nursing (lactating) women.

Inclusion Criteria

Exclusion Criteria

1. Signed Informed Consent Form
2. ≥ 1 year of age
3. Disease status
1. Patients must have high-risk neuroblastoma according to Children's Oncology Group risk classification at the time of study enrollment.
2. Histologically confirmed diagnosis of neuroblastoma that is recurrent/relapsed/persistent according to International Neuroblastoma Response Criteria
3. Patients must have evaluable or measurable disease at enrollment
4. Adequate organ function
5. Adequate performance status defined as Lanksy or Karnofsky performance score ≥60.
6. Subjects of reproductive potential must agree to use acceptable birth control methods.

1. Patients with active hepatitis B or active hepatitis C.
2. Patients with HIV infection.
3. Patients with uncontrolled active infection
4. Patients with primary or acquired immunodeficiency disorder.
5. Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or immunosuppression during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well.
6. Patients with actively progressing Central Nervous System metastases, including parenchymal or leptomeningeal involvement.
7. Active medical disorder that, in the opinion of the investigator, would substantially increase. the risk of uncontrollable Cytokine Release Syndrome and/or neurotoxicity.
8. Patients with congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.
9. Patients who have received any live vaccines within 30 days prior to enrollment.
10. Pregnant or nursing (lactating) women.

Contacts and Locations

Study Contact

Melissa Varghese

CONTACT

8455535358

Varghesem@chop.edu

Yael Mosse, MD

CONTACT

mosse@chop.edu

Principal Investigator

Lisa Wray, MD

PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Stephan Grupp MD PhD

Lisa Wray, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-23

Study Completion Date2026-01-30

Study Record Updates

Study Start Date2023-05-23

Study Completion Date2026-01-30

Terms related to this study

Additional Relevant MeSH Terms

Refractory Neuroblastoma
Relapsed Neuroblastoma
High-risk Neuroblastoma