← Back to Search

CAR T-cell Therapy

Treatment (IL-2, GM-CSF, GD2Bi-aATC) for Neuroblastoma

Phase 1 & 2
Waitlist Available
Led By Maxim Yankelevich
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

Previous research has demonstrated that investigators can coat (arm) T cells with a special molecule called GD2 bispecific antibody that will help T cells recognize neuroblastoma and osteosarcoma cells and kill them. This bispecific antibody recognizes GD2, a protein found on almost all neuroblastoma and osteosarcoma cells. The investigators put the GD2 bispecific antibody on T cells and give large numbers of these T cells back to patients. The investigators think that these T cells may have a better chance of killing GD2 expressing tumor cells when they are armed with GD2 bispecific antibody. This trial studies the side effects and best dose of activated T cells armed with GD2 bispecific antibody and how well they work in treating patients with neuroblastoma, osteosarcoma, and other GD2-positive solid tumors.

Eligible Conditions
  • Neuroblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) of GD2Bi-aATC
Secondary outcome measures
Anti-tumor activity
Immune responses after GD2Bi-aATC infusions

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (IL-2, GM-CSF, GD2Bi-aATC)Experimental Treatment4 Interventions
Patients receive IL-2 SC daily on days -2 to 35, GM-CSF SC twice weekly x 5 weeks, and GD2Bi-aATC IV over 30 minutes twice weekly x 4 weeks for a total of 8 infusions. Laboratory evaluations of immune responses are obtained prior and after immunotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
FDA approved
Sargramostim
FDA approved

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,244,991 Total Patients Enrolled
1 Trials studying Neuroblastoma
4 Patients Enrolled for Neuroblastoma
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,627 Total Patients Enrolled
205 Trials studying Neuroblastoma
53,688 Patients Enrolled for Neuroblastoma
Maxim YankelevichPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute
1 Previous Clinical Trials
23 Total Patients Enrolled
1 Trials studying Neuroblastoma
23 Patients Enrolled for Neuroblastoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Apr 2025