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Monoclonal Antibodies

Gamma Delta T Cell Immunotherapy + Chemoimmunotherapy for Neuroblastoma (Aflac-NBL-2002 Trial)

Phase 1

Recruiting

Led By Kelly Goldsmith, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Refractory disease: A best overall response of no response/stable disease since diagnosis of high risk neuroblastoma AND after at least 4 courses of high risk neuroblastoma induction therapy.

- Renal Function: Patients must have adequate renal function defined as age-adjusted serum creatinine ≤1.5 ULN for age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 of protocol therapy through 30 days following end of protocol therapy

Awards & highlights

Aflac-NBL-2002 Trial Summary

This trial is testing a new immunotherapy treatment for neuroblastoma that uses gamma delta T cells in combination with other drugs. The goal is to improve upon GD2 chemoimmunotherapy regimens for neuroblastoma by delivering standard drugs like temozolomide, irinotecan, and dinutuximab in combination with gamma delta T cells.

Who is the study for?

This trial is for children over 12 months old with high-risk neuroblastoma that's relapsed or not responded to treatment. They need normal heart, kidney, liver, and bone marrow function and can't have had prior T cell therapy or stem cell transplant. No major organ system diseases, active infections, or uncontrolled cardiac issues are allowed.Check my eligibility

What is being tested?

The study tests a new combination of treatments for aggressive childhood cancer: γδ T cells from donors plus standard drugs (dinutuximab, temozolomide, irinotecan) and zoledronate. It aims to find the safest dose and see how well it works in kids with tough-to-treat neuroblastoma.See study design

What are the potential side effects?

Potential side effects include reactions related to immune response due to γδ T cells and dinutuximab infusion; toxicity from chemotherapy agents like temozolomide and irinotecan affecting blood counts; nausea; fatigue; liver impact; as well as risks associated with zoledronate such as bone pain.

Aflac-NBL-2002 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My neuroblastoma has not improved after 4 treatment cycles.

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My kidney function is within the normal range for my age.

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My liver tests are within the required range.

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I have been diagnosed with neuroblastoma confirmed by tests.

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My neuroblastoma has partially responded after 4+ treatment rounds.

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I don't have trouble breathing at rest or during exercise.

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I am older than 12 months.

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My blood cell counts meet the required levels and I don't need blood transfusions.

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My heart's pumping ability is normal, confirmed by a heart scan.

Aflac-NBL-2002 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 of protocol therapy through 30 days following end of protocol therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 of protocol therapy through 30 days following end of protocol therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 of protocol therapy through 30 days following end of protocol therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose/Recommended Phase 2 Dose of gamma delta T cells

Secondary outcome measures

Describe Hematological Toxicities

Describe Non-Hematological Toxicities

Overall Response

Aflac-NBL-2002 Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation Phase I cohortExperimental Treatment1 Intervention

Subjects will be assigned a cell therapy dose level at time of registration. The entry dose level is Dose Level 1, with escalation up to Dose Level 3 following a 3 + 3 dose escalation design. If there is no evidence of progression, patients may receive up to a maximum of 4 courses. Each course includes two administrations of γδ T cells, administered one week apart. Toxicity, for deciding dose escalation and defining the MTD, will be evaluated during Course 1. Disease response assessment will be done after Courses 2 and 4. Dinutuximab (17.5 mg/m2), temozolomide (100 mg/m2), irinotecan (50 mg/m2) and zoledronate (0.0125 mg/kg/dose) will be consistent across all dose levels.The same donor for γδ T cell will be used for both cell therapy product infusions per course. Treatment of the first two subjects in each dose escalation cohort will be staggered. The second subject will not be enrolled until the first subject completes the DLT observation interval (minimum of 21 days).

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,638 Previous Clinical Trials

2,560,508 Total Patients Enrolled

5 Trials studying Neuroblastoma

3,484 Patients Enrolled for Neuroblastoma

Kelly Goldsmith, MDPrincipal InvestigatorAssociate Profesor

1 Previous Clinical Trials

13 Total Patients Enrolled

1 Trials studying Neuroblastoma

13 Patients Enrolled for Neuroblastoma

Media Library

Dinutuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05400603 — Phase 1

Neuroblastoma Research Study Groups: Dose Escalation Phase I cohort

Neuroblastoma Clinical Trial 2023: Dinutuximab Highlights & Side Effects. Trial Name: NCT05400603 — Phase 1

Dinutuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05400603 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the administration approved a combination of Ex Vivo Expanded Allogeneic γδ T Cells, Dinutuximab, Temozolomide, Irinotecan and Zoledronate as therapeutics?

"The safety of Ex Vivo Expanded Allogeneic γδ T Cells in Combination with Dinutuximab, Temozolomide, Irinotecan and Zoledronate is estimated to be a score of 1 since this is an early-phase trial where efficacy and safety data are limited."

Answered by AI

Is this research endeavor still recruiting participants?

"Data available on clinicaltrials.gov indicates that recruitment for this particular medical trial has ended, with the original post dated November 1st 2022 and its last update occurring October 6th 2022. Despite no longer seeking participants in this specific study, 161 other investigations are actively recruiting individuals right now."

Answered by AI

Does the current research include participants aged 50 and over?

"The age range for enrolment in this trial encompasses individuals aged from one year old to 16 years. There are 159 studies accommodating minors and 42 research opportunities for those over 65."

Answered by AI

Might I be a viable candidate for the current clinical trial?

"This trial seeks to recruit two dozen children aged 12 months - 16 years with neuroblastoma, who meet the following selection criteria: must be ≥12 months at registration, diagnosed by histology or elevated urinary catecholamines; classified as high-risk according to COG standards; recurrent/progressive disease post-initial diagnosis of high risk; refractory response after 4 induction treatments for HRNB. Patients with persistent disease and 2+ MIBG avid sites may qualify without biopsy confirmation, but those exhibiting 1 site need evidence from bone marrow, bone, or soft tissue samples collected pre-registration or post prior therapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kelly Goldsmith 2023. "Allogeneic Expanded Gamma Delta T Cells With GD2 Chemoimmunotherapy in Relapsed or Refractory Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05400603.

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