Actively Recruiting
A Phase I Study of Allogeneic Expanded Gamma Delta T Cells with Dinutuximab, Temozolomide, Irinotecan, and Zoledronate in Children with Refractory or Relapsed Neuroblastoma or Osteosarcoma
Led by Emory University · Updated on 2025-12-26
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find the highest safe dose and the recommended dose for Phase II of a treatment using allogeneic expanded gamma delta (γδ) T cells alongside dinutuximab, temozolomide, irinotecan, and zoledronate in children with difficult-to-treat or returning neuroblastoma or osteosarcoma. These cancers are aggressive pediatric solid tumors with survival rates under 50%, highlighting the need for new targeted therapies. The study focuses on safety, toxicity, and early effectiveness of this novel cell therapy combined with chemotherapy and immunotherapy. Participants will receive a single infusion of donor-derived, expanded γδ T cells on Day 6 after completing a regimen of dinutuximab, temozolomide, irinotecan, and zoledronate. If eligible, a second γδ T cell infusion occurs on Day 13. The γδ T cell dose starts at 3 million cells per kilogram and may increase up to 30 million cells per kilogram following a standard dose escalation design. Patients may receive up to four courses, each including two infusions one week apart. Chemotherapy and immunotherapy doses remain consistent across dose levels. During the study, participants undergo evaluations for side effects and disease response after initial and later treatment courses. Blood samples may also be collected and stored for future research. Safety monitoring includes watching for toxicities from enrollment through 30 days after treatment. The maximum tolerated dose and recommended Phase II dose will be determined within 21 days. Participants will be followed for treatment effects and side effects throughout the study period.
CONDITIONS
Brief 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.
- Confirmed diagnosis of neuroblastoma, ganglioneuroblastoma, or osteosarcoma.
- Disease is refractory, relapsed, or progressive neuroblastoma or relapsed/refractory osteosarcoma.
- Measurable or evaluable disease by accepted criteria.
- Lansky or Karnofsky performance score of 50 or higher.
- Fully recovered from acute toxic effects of prior therapies.
- Prior dinutuximab, temozolomide, irinotecan, zoledronate, or chemoimmunotherapy allowed.
- Adequate hematologic, renal, liver, cardiac, and pulmonary function as defined.
You will not qualify if you...
- Prior T cell therapy.
- Pregnancy or breastfeeding, or unwillingness to use contraception.
- Unable to comply with safety monitoring.
- Active central nervous system disease (except skull disease with intracranial extension).
- Prior allogeneic stem cell transplant.
- On hemodialysis.
- Active or uncontrolled infection.
- Known HIV, hepatitis B or C infection.
- Disease compromising ability to tolerate therapy.
- Permanent discontinuation of dinutuximab due to toxicity.
- Serious uncontrolled cardiac arrhythmias or myocarditis.
- Received live vaccines within 30 days before enrollment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 courses, each course lasting approximately 2 weeks
Participants receive dinutuximab, temozolomide, irinotecan, and zoledronate combined with infusions of allogeneic expanded gamma delta T cells. The first cell infusion occurs on Day 6 and a second infusion may be given on Day 13 if criteria are met. Up to 4 courses can be given, each course including two infusions one week apart. Dose levels are escalated based on safety evaluation.
Multiple visits weekly during each course for infusions and monitoring
Duration - 30 days following end of protocol therapy
Participants are monitored for toxicities and overall response through 30 days following the end of protocol therapy.
Several visits during the 30-day follow-up period
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
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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