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New treatment option for Neuroblastoma
Official title NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial
ClinicalTrials.gov ID: NCT06450041
What this study is testing
What is Universal Donor (UD) TGFβi NK Cells?
Universal Donor (UD) TGFβi NK Cells is an investigational medicine, given as an once-daily, 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
- This is a phase II study looking at patient response to treatment with the combination dinutuximab, temozolomide, irinotecan, and GM-CSF.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 31
You may be able to join if
- Patients must be ≥ 1 year and ≤31 years of age at the time of enrollment on the study.
- Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone...
- Patients must have high-risk neuroblastoma according to COG risk classification at the time of study registration. Patients whose disease was...
- Patients must have at least ONE of the following: 1) Recurrent/progressive disease after the diagnosis of high risk neuroblastoma at any time prior...
- Patients must have at least ONE of the following (lesions may have received prior radiation therapy as long as they meet the other criteria listed...
You likely can't join if
- Patients who are pregnant, breast feeding, or unwilling to use effective contraception during the 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 disease of any major organ system that would compromise their ability to withstand therapy.
- Patients with \> Grade 2 diarrhea.
- Patients who have undergone a prior allogeneic stem cell or solid organ transplant.
- Patients who are on hemodialysis.
See the full eligibility criteria
Who can join
- Patients must be ≥ 1 year and ≤31 years of age at the time of enrollment on the study.
- Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines.
- Patients must have high-risk neuroblastoma according to COG risk classification at the time of study registration. Patients whose disease was initially considered low or intermediate risk but then reclassified as...
- Patients must have at least ONE of the following: 1) Recurrent/progressive disease after the diagnosis of high risk neuroblastoma at any time prior to enrollment - regardless of response to frontline therapy. (Note that...
- Patients must have at least ONE of the following (lesions may have received prior radiation therapy as long as they meet the other criteria listed below) based on institutional assessment: 1) Bone Sites
- a) MIBG avid tumors: patients must meet one of the following criteria: a. Patients with recurrent/progressive or refractory disease: i. Must have at least one MIBG avid bone site on planar imaging OR ii. Must have \> 2...
- SIZE: Lesion can be accurately measured in at least one dimension with a longest diameter ≥ 10 mm, or for discrete lymph nodes ≥ 15mm on short axis. Lesions meeting size criteria will be considered measurable.
- In addition to size, a lesion needs to meet ONE of the following criteria except for patients with parenchymal CNS lesions which will only need to meet size criteria:
- For MIBG avid tumors: lesion must be MIBG avid and meet one of the following criteria:
- For patients with recurrent/progressive or refractory disease: i. No biopsy is required
- For patients with persistent disease: i. If a patient has 3 or more MIBG avid sites by planar or SPECT imaging (including soft tissue and/or bone), then no biopsy is required. ii. If a patient has only 1 or 2 MIBG avid...
- Patients must have a Lansky (≤ 16 years) or Karnofsky (\> 16 years) score of ≥ 50 (Appendix I). Note: Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory...
- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study registration.
- Patients must not have received the therapies indicated below after disease evaluation or within the specified time period prior to registration on this study as follows:
- Myelosuppressive chemotherapy: must not have received within 2 weeks prior to registration.
- Biologic anti-neoplastics- agents not known to be associated with reduced platelet or ANC counts (including retinoids): must not have received within 7 days prior to registration.
- Monoclonal antibodies: must not have received last dose within 14 days of registration and resolution of all toxicities.
- Cellular Therapy (e.g. modified T cells, NK cells, dentritic cells etc.): must not have received within 3 weeks and resolution of all toxicities.
- Radiation: must not have received small port radiation within 7 days prior to registration, large field radiation within 12 weeks, and 131I-MIBG therapy or other radiopharmaceutical within 6 weeks.
- Hematopoietic Stem Cell Transplant- none following myeloblative therapy within 6 weeks
- Any other investigational agents (covered under another IND within 14 days
- Strong inducers or inhibitors of CYP3A4
- Hematologic Function: NOTE: No short acting hematopoietic growth factors within 7 days of blood draw documenting eligibility and no long-acting hematopoietic growth factors within 14 days of blood draw documenting...
- Absolute Neutrophil count ≥750/µL
- Platelet count ≥ 75,000/µL, transfusion independent (no platelet transfusions within 7 days of blood draw documenting eligibility) Patients with known bone marrow metastatic disease will be eligible for study as long as...
- 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,
- SGPT (ALT) ≤ 135 U/L (≤ 3x ULN). Note that for ALT, the upper limit of normal for all sites is defined as 45 U/L.
- Cardiac Function
- Normal ejection fraction (≥ 55%) documented by either echocardiogram OR
- Normal fractional shortening (≥ 27%) documented by echocardiogram
- Pulmonary Function No evidence of dyspnea at rest
- Reproductive Function All females ≥ Tanner stage 2 and post-menarchal of childbearing potential must have a negative beta-HCG within 7 days prior to study registration. Males and females of reproductive age and...
- Central Nervous System (CNS) Patients with a history of intraparenchymal or leptomeningeal based CNS disease must have no clinical or radiological evidence of active CNS disease at the time of study enrollment. Patients...
What rules you out
- Patients who are pregnant, breast feeding, or unwilling to use effective contraception during the 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 disease of any major organ system that would compromise their ability to withstand therapy.
- Patients with \> Grade 2 diarrhea.
- Patients who have undergone a prior allogeneic stem cell or solid organ 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.
- Patients with 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 must not have been diagnosed with any other malignancy.
- Patients with history of Grade 4 Allergic reactions to anti-GD2 antibody therapy or reactions that caused permanent discontinuation of therapy.
- Patients with history of progressive disease while receiving therapy per ANBL1221.
- Patient declines participation in the NANT biology study and the site has not been granted a waiver from participation.
- Systemic Steroids and Immunosuppressive Medications
- Patients who have received pharmacologic doses of systemic steroids 7 days prior to study registration or likely to require them after study registration. Note: Exceptions are the following:
- Patients known to require 2 mg/kg or less of hydrocortisone (or an equivalent dose of an alternative corticosteroid) as premedication for blood product administration.
- The use of conventional doses of inhaled steroids for the treatment of asthma
- The use of physiologic doses of steroids for patients with known adrenal insufficiency.
- Patients on any other immunosuppressive medications (e.g., cyclosporine, tacrolimus) at the time of study registration.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Memphis, Tennessee, United States
- Dallas, Texas, United States
- Fort Worth, Texas, United States
- Seattle, Washington, 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, 1 year to 31 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.