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OncoMatch/Clinical Trials/NCT05400603

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

Is NCT05400603 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Ex Vivo Expanded Allogeneic γδ T Cells in Combination with Dinutuximab, Temozolomide, Irinotecan and Zoledronate for neuroblastoma.

Phase 1RecruitingEmory UniversityNCT05400603Data as of May 2026

Treatment: Ex Vivo Expanded Allogeneic γδ T Cells in Combination with Dinutuximab, Temozolomide, Irinotecan and ZoledronateThe 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

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Extracted eligibility criteria

Cancer type

Neuroblastoma

Osteosarcoma

Prior therapy

Cannot have received: T cell therapy

Prior T cell therapy is excluded

Cannot have received: allogeneic stem cell transplant

Patients with prior allogeneic stem cell transplant

Lab requirements

Blood counts

Absolute Neutrophil count ≥750/uL and platelet count ≥ 75,000/µl, transfusion independent

Kidney function

age-adjusted serum creatinine ≤1.5 ULN for age

Liver function

Total bilirubin ≤ 1.5 x ULN for age and serum glutamic-pyruvic transaminase (SGPT) (ALT) ≤ 135 U/L (≤ 3x ULN)

Cardiac function

Normal ejection fraction (≥ 55%) documented by either echocardiogram or radionuclide multigated acquisition scan (MUGA) evaluation OR Normal fractional shortening (≥ 27%) documented by echocardiogram

Hematologic Functions : Absolute Neutrofil count ≥750/uL and platelet count ≥ 75,000/µl, transfusion independent. Renal Function: Patients must have adequate renal function defined as age-adjusted serum creatinine ≤1.5 ULN for age. Liver Function: Total bilirubin ≤ 1.5 x ULN for age and serum glutamic-pyruvic transaminase (SGPT) (ALT) ≤ 135 U/L (≤ 3x ULN). Cardiac Function: Normal ejection fraction (≥ 55%) documented by either echocardiogram or radionuclide multigated acquisition scan (MUGA) evaluation OR Normal fractional shortening (≥ 27%) documented by echocardiogram. Pulmonary Function: Normal pulmonary function with no evidence of dyspnea at rest, no exercise intolerance.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Children's Healthcare of Atlanta · Atlanta, Georgia

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