Actively Recruiting
Allogeneic Expanded Gamma Delta T Cells With GD2 Chemoimmunotherapy in Relapsed /Refractory Neuroblastoma or Refractory/ Relapsed Osteosarcoma
Led by Emory University · Updated on 2025-12-26
24
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of allogeneic expanded γδ T cells when delivered with Dinutuximab, temozolomide, irinotecan, and zoledronate in children with refractory or recurrent neuroblastoma or refractory/ relapsed osteosarcoma as well as to define the toxicities of allogeneic expanded γδ T cells when delivered with Dinutuximab, temozolomide, irinotecan, and zoledronate
CONDITIONS
Official Title
Allogeneic Expanded Gamma Delta T Cells With GD2 Chemoimmunotherapy in Relapsed /Refractory Neuroblastoma or Refractory/ Relapsed Osteosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be at least 12 months old at enrollment.
- Diagnosis confirmed as neuroblastoma, ganglioneuroblastoma, or osteosarcoma.
- Patients have refractory, relapsed, or progressive neuroblastoma or osteosarcoma.
- Patients have measurable or evaluable disease by standard criteria.
- Lansky score of at least 50 for patients 16 years or younger or Karnofsky score over 16 years old.
- Fully recovered from acute effects of prior chemotherapy, immunotherapy, or radiotherapy.
- Prior dinutuximab, temozolomide, zoledronate, or combined chemoimmunotherapy allowed.
- Hematologic function: Absolute neutrophil count ≥ 750/µL and platelet count ≥ 75,000/µL, transfusion independent.
- Renal function adequate with age-adjusted serum creatinine ≤ 1.5 times upper limit of normal.
- Liver function: Total bilirubin ≤ 1.5 times upper limit of normal and ALT ≤ 135 U/L (≤ 3 times upper limit).
- Cardiac function normal with ejection fraction ≥ 55% or fractional shortening ≥ 27%.
- Pulmonary function normal without dyspnea at rest or exercise intolerance.
You will not qualify if you...
- Prior T cell therapy.
- Pregnancy, breastfeeding, or unwillingness to use effective contraception.
- Inability to comply with safety monitoring.
- Known active central nervous system disease (excluding skull disease with intracranial extension).
- Prior allogeneic stem cell transplant.
- Patients on hemodialysis.
- Active or uncontrolled infection.
- Known HIV, hepatitis B, or hepatitis C infection.
- Disease affecting major organ systems that prevents withstanding therapy.
- Permanent discontinuation of dinutuximab due to toxicity.
- Serious, uncontrolled cardiac arrhythmias.
- History of myocarditis.
- Receipt of any live vaccine within 30 days before enrollment.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
K
Kelly Goldsmith, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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