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CAR T-cell Therapy

GD2-CAR-expressing Autologous T-lymphocytes for Osteosarcoma

Phase 1
Waitlist Available
Led By Rosandra N Kaplan
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For the dose escalation cohort, must have evaluable or measurable disease at enrollment
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

Study Summary

This trial is testing an immune cell therapy to see if it is effective in treating patients with osteosarcoma or neuroblastoma.

Eligible Conditions
  • Osteosarcoma
  • Neuroblastoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must have a disease that can be measured or evaluated at the start of the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best response to GD2CART cells
Feasibility of producing GD2-CAR-expressing autologous T-lymphocytes (GD2CART) cells
Incidence of adverse events (AEs)
+1 more
Secondary outcome measures
Capacity for rimiducid (AP1903) to reverse unacceptable toxicity related to GD2CART administration
Feasibility and tolerability of a second infusion of GD2CART cells
Other outcome measures
Biomarkers
GD2 expression
Persistence of GD2CART cells

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (GD2 CAR T)Experimental Treatment9 Interventions
LYMPHODEPLETION CHEMOTHERAPY: Patients receive fludarabine phosphate IV daily on days -5 to -2 and cyclophosphamide IV daily on days -4 to -2. GD2CART: Patients receive GD2CART cells IV on day 0. Patients also undergo ECHO, MUGA or cardiac MRI scan during screening, blood sample collection throughout the trial, and tumor biopsies as clinically indicated. In addition, patients undergo standard imaging scans throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1020
Echocardiography
2013
Completed Phase 4
~11670
Biospecimen Collection
2004
Completed Phase 2
~1920
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine Phosphate
1997
Completed Phase 3
~2390

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,613 Previous Clinical Trials
40,918,258 Total Patients Enrolled
104 Trials studying Osteosarcoma
21,289 Patients Enrolled for Osteosarcoma
Rosandra N KaplanPrincipal InvestigatorCancer Immunotherapy Trials Network

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health risks can be associated with GD2-CAR-expressing Autologous T-lymphocytes?

"The safety of GD2-CAR-expressing Autologous T-lymphocytes is thought to be a 1, as this Phase 1 trial only has limited data supporting its efficacy and security."

Answered by AI

What therapeutic purpose is GD2-CAR-expressing Autologous T-lymphocytes typically used for?

"GD2-CAR expressing autologous T-lymphocytes is a therapeutic option for multiple sclerosis, as well as various forms of lymphoma and leukemia, myelocytic disease, acute leukemias, and retinoblastoma."

Answered by AI

How successful have previous experiments been involving GD2-CAR-expressing Autologous T-lymphocytes?

"First examined at the City of Hope Comprehensive Cancer Center in 1997, GD2-CAR-expressing Autologous T-lymphocytes has been subject to 1275 clinical trials. Currently 889 studies are recruiting participants with many located within Madison, Wisconsin."

Answered by AI

How many individuals are included in this research experiment?

"Affirmative. According to clinicaltrials.gov, recruitment for this experiment is ongoing after first being posted on June 11th 2021 and last updated July 15th 2022. 67 individuals are required from 3 research centres in total."

Answered by AI

Has recruitment for this experiment begun yet?

"Agreed. The clinicaltrials.gov website indicates that, as of the 15th July 2022, this medical trial is still searching for 67 volunteers from 3 separate locations to participate in their research. This study was initially posted on June 11th 2021."

Answered by AI
~45 spots leftby Dec 2040