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New treatment option for Neuroblastoma
Official title Allogeneic Expanded Gamma Delta T Cells With GD2 Chemoimmunotherapy in Relapsed /Refractory Neuroblastoma or Refractory/ Relapsed Osteosarcoma
ClinicalTrials.gov ID: NCT05400603
What this study is testing
What is Ex Vivo Expanded Allogeneic γδ T Cells in Combination with Dinutuximab, Temozolomide, Irinotecan and Zoledronate?
Ex Vivo Expanded Allogeneic γδ T Cells in Combination with Dinutuximab, Temozolomide, Irinotecan and Zoledronate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuroblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Patients must be ≥ 12 months of age at the time of enrollment in the study.
- Diagnosis: Histological confirmation of neuroblastoma or ganglioneuroblastoma at initial diagnosis. (Bone marrow samples with positive catecholamines...
- Response to prior therapy:
- High-risk neuroblastoma with refractory, relapsed or progressive disease, defined as:
- First or greater relapse of neuroblastoma following completion of aggressive multi- drug frontline therapy.
You likely can't join if
- Prior T cell therapy
- Pregnancy, breast feeding, or unwillingness to use effective contraception during the study will not be entered on this study.
- Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- Patients with known active Central Nervous System (CNS) disease (excluding skull disease with intracranial extension). Patients with a history of CNS...
- Patients with prior allogeneic stem cell transplant
- Patients who are on hemodialysis
See the full eligibility criteria
- Patients must be ≥ 12 months of age at the time of enrollment in the study.
- Diagnosis: Histological confirmation of neuroblastoma or ganglioneuroblastoma at initial diagnosis. (Bone marrow samples with positive catecholamines are acceptable as confirmation of neuroblastoma) OR histological...
- Response to prior therapy:
- High-risk neuroblastoma with refractory, relapsed or progressive disease, defined as:
- First or greater relapse of neuroblastoma following completion of aggressive multi- drug frontline therapy.
- First episode of progressive neuroblastoma during aggressive multi-drug frontline therapy.
- Persistent/refractory neuroblastoma as defined by less than a complete response by the revised International Neuroblastoma Response Criteria (INRC) after at least 4 cycles of aggressive multidrug induction chemotherapy...
- Note that this excludes patients initially considered low or intermediate-risk neuroblastoma that progressed to high-risk disease but the patient has not progressed after the diagnosis of high-risk neuroblastoma.
- Relapsed or refractory osteosarcoma that is not responsive to standard treatment
- Disease Status
- Patients must have measurable or evaluable disease per revised INRC for people with neuroblastoma or measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for people with...
- Performance Level:Patients must have a Lansky (≤16 years) or Karnofsky (\>16 years) score of ≥50
- Prior Therapy
- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy before study registration.
- Prior dinutuximab therapy is allowed regardless of prior response or progression on dinutuximab
- Prior temozolomide therapy is allowed
- Prior zoledronate is allowed
- Prior dinutuximab/temozolomide/irinotecan chemoimmunotherapy is allowed
- Prior T cell therapy is excluded
- Organ Function Requirements:
- 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.
- Prior T cell therapy
- Pregnancy, breast feeding, or unwillingness to use effective contraception during the study will not be entered on this study.
- Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- Patients with known active Central Nervous System (CNS) disease (excluding skull disease with intracranial extension). Patients with a history of CNS disease are required to have a brain CT and/ or MRI at study...
- Patients with prior allogeneic stem cell transplant
- Patients who are on hemodialysis
- Patients with an active or uncontrolled infection. Patients on prolonged antifungal therapy are still eligible if they are culture negative, afebrile, and meet other organ function criteria
- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. Testing is not required in the absence of clinical findings or suspicion.
- Patients with disease of any major organ system that would compromise their ability to withstand therapy.
- Patients who have had to permanently discontinue Dinutuximab due to toxicity
- Patients with serious, uncontrolled cardiac arrhythmias
- Patients with a history of myocarditis
- Patients who have received any live vaccines within 30 days before enrollment
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.