RecruitingPhase 1NCT05400603

Allogeneic Expanded Gamma Delta T Cells With GD2 Chemoimmunotherapy in Relapsed /Refractory Neuroblastoma or Refractory/ Relapsed Osteosarcoma

A Phase I Study of Allogeneic Ex Vivo Expanded Gamma Delta (γδ) T Cells in Combination With Dinutuximab, Temozolomide, Irinotecan, and Zoledronate in Children With Refractory/ Relapsed, or Progressive Neuroblastoma or Refractory/ Relapsed Osteosarcoma

Sponsor

Emory University

Enrollment

24 participants

Start Date

Nov 6, 2023

Study Type

INTERVENTIONAL

Conditions

Neuroblastoma Refractory Osteosarcoma Refractory Neuroblastoma Relapsed Neuroblastoma Relapsed Osteosarcoma

Summary

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

Eligibility

Min Age: 12 Months

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment using donor gamma-delta T cells (a specialized type of immune cell) combined with a targeted antibody against a protein called GD2, in children and young adults with neuroblastoma or osteosarcoma that has come back or has not responded to treatment. **You may be eligible if...** - You (or your child) are at least 12 months old - You have been diagnosed with neuroblastoma, ganglioneuroblastoma, or osteosarcoma confirmed by biopsy - Your cancer has relapsed or has not responded to prior treatment - You are well enough to participate (Lansky/Karnofsky performance score ≥50) **You may NOT be eligible if...** - You have active, uncontrolled infection - You have severe organ dysfunction (heart, liver, or kidney) - You have had a prior stem cell transplant within a certain time period - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTEx Vivo Expanded Allogeneic γδ T Cells in Combination with Dinutuximab, Temozolomide, Irinotecan and Zoledronate

The cell dose will be based on the subject's body weight. Subjects will receive a single infusion of third party, ex vivo expanded, frozen then thawed γδ T cell product at a dose of 3 x 106 cells/kg on Day 6 and then if they meet criteria for subsequent γδ T cell dose will receive a second dose of 3 x 106 cells/kg on Day 13. The dose will be escalated to 1 x 10\^7 and then 3 x 10\^7 cells/kg. In absence of any dose limiting toxicity, 3 x 10\^7 cells/kg will be accepted as the maximal dose. Dinutuximab (17.5 mg/m2), temozolomide (100 mg/m2),irinotecan (50 mg/m2) and zoledronic acid (0.0125 mg/kg/dose) will be consistent across all dose levels. Max γδ T cell dose will not exceed Level 3 dosing at 50 kg: 1.5×10⁹ total γδ T cells.

Locations(1)

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

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NCT05400603

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