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New treatment option for Brain Tumor, Pediatric
Official title GD2-CAR T Cells for Pediatric Brain Tumours
ClinicalTrials.gov ID: NCT05298995
What this study is testing
What is GD2-CART01 (iC9-GD2-CAR T-cells)?
GD2-CART01 (iC9-GD2-CAR T-cells) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for brain tumor, pediatric.
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 purpose of this study is to test the safety and efficacy of iC9-GD2-CAR T-cells, a third generation (4.1BB-CD28) CAR T cell treatment targeting GD2 in paediatric or young adult patients affected by relapsed/refractory malignant central nervous system (CNS) tumors. In order to improve the safety of the approach, the suicide gene inducible Caspase 9 (iC9) has been included.
- 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 6 to 30
You may be able to join if
- Imaging assessments performed within 14 days of start of treatment
- Age: 6months-30years
- Measurable or evaluable disease on at least 2 dimensions on MRI at the time of treatment enrollment
- Karnofsky/Lansky≥60
- Recoverfromthetoxiceffectsofpreviousradiationandchemotherapies:grade4and or 3 non-hematologic toxicities must have resolved to grade ≤ 2; in presence...
You likely can't join if
- Pregnant or lactating women
- Severe,uncontrolledactiveinfections
- HIV or active HCV and/or HBV infection
- Rapidly progressive disease with life expectancy \< 6 weeks
- Historyofgrade3or4hypersensitivitytomurineprotein-containingproducts
- Hepatic function: inadequate liver function defined as total bilirubin \> 4x upper limit of normal (ULN) or transaminase (ALT and AST) \> 6 x ULN...
See the full eligibility criteria
- Imaging assessments performed within 14 days of start of treatment
- Age: 6months-30years
- Measurable or evaluable disease on at least 2 dimensions on MRI at the time of treatment enrollment
- Karnofsky/Lansky≥60
- Recoverfromthetoxiceffectsofpreviousradiationandchemotherapies:grade4and or 3 non-hematologic toxicities must have resolved to grade ≤ 2; in presence of chronic complications (i.e. treatment-associated...
- Positioning of an implantable intraventricular access device (CodmanHolterRickham reservoir, Integra LifeSciences, NJ, U.S.A) and a microdialysis probe (71 high cutoff microdialysis bolt catheter, M Dialysis AB...
- Written and signed informed consent from patients, parents or legal guardians. For people \< 18 year-old their legal guardian must give informed consent. In addition, pediatric people will be included in age-appropriate...
- Patients of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen
- Females of childbearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus
- Pregnant or lactating women
- Severe,uncontrolledactiveinfections
- HIV or active HCV and/or HBV infection
- Rapidly progressive disease with life expectancy \< 6 weeks
- Historyofgrade3or4hypersensitivitytomurineprotein-containingproducts
- Hepatic function: inadequate liver function defined as total bilirubin \> 4x upper limit of normal (ULN) or transaminase (ALT and AST) \> 6 x ULN based on age and laboratory specific normal ranges
- Renal function: serum creatinine \> 3x ULN for age
- Blood oxygen saturation \< 90%
- Cardiac function: left ventricular ejection fraction lower than 45% by ECHO
- Marrow function: absolute neutrophils count (ANC) lower than 500/mm3 and/or platelets lower than 20.000 (not reached by transfusion)
- Congestive heart failure, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the principal investigator (PI) would pose an unacceptable...
- If receiving glucocorticoids, patient must be on a stable or weaning dose for at least 7 days prior to infusion. Recent or current use of inhaled/topical/non- absorbable steroids is not exclusionary. people receiving...
- Systemic chemotherapy in the 3 weeks preceding infusion
- Immunosuppressive agents less than or equal to 30 days
- Radiation therapy must have been completed at least 6 weeks prior to enrollment
- Otheranti-neoplasticinvestigationalagentscurrentlyorwithin30dayspriorto start of protocol therapy 13.Patient-derived GD2-CART01 production failure: vitality \ 20%, RCR positivity, Vector Copy Number \>10, non-sterility...
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Italy, Italy
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, 6 months to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, Italy, Italy. 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.