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New treatment option for Diffuse Intrinsic Pontine Glioma
Official title C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B)
ClinicalTrials.gov ID: NCT04099797
What this study is testing
What is C7R-GD2.CART cells (IV and ICV infusion)?
C7R-GD2.CART cells (IV and ICV infusion) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diffuse intrinsic pontine glioma.
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
- In this study, there are two treatment groups called Cohort 1 and Cohort 2. Cohort 1 is for patients with diffuse midline glioma, diffuse intrinsic pontine glioma, medulloblastoma, or another rare high-grade glioma that expresses GD2.
- Phase 1: an early, usually small safety study
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 25
You may be able to join if
- Procurement Cohort 1:
- Histologically confirmed, GD2-expressing newly diagnosed DMG/HGG (including pontine) or confirmation of H3K27 alteration if sufficient tissue for GD2...
- Tumors less than 5 cm in maximum dimension at enrollment
- Tumors with ≤25% increase in size (on any dimension) on MRI 4-8 weeks post-radiotherapy remain eligible for study
- Tumors with \>25% increase in size on post-radiation imaging may be reassessed with repeat MRI in 4-6 weeks, and are eligible if tumor size is...
You likely can't join if
- Patients who are pregnant or breast feeding
- Any patient with other risk factors for whom administration of investigational agent is deemed not in the patient's best interest, in the opinion of...
- Histologically confirmed, GD2-expressing newly diagnosed DMG/HGG (including pontine) or confirmation of H3K27 alteration if sufficient tissue for GD2...
- Tumors less than 5 cm in maximum dimension at enrollment
- Tumors with ≤25% increase in size (on any dimension) on MRI 4-8 weeks post-radiotherapy remain eligible for study
- Tumors with \>25% increase in size on post-radiation imaging may be reassessed with repeat MRI in 4-6 weeks, and are eligible if tumor size is...
See the full eligibility criteria
- Procurement Cohort 1:
- Histologically confirmed, GD2-expressing newly diagnosed DMG/HGG (including pontine) or confirmation of H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available. Newly diagnosed is defined as prior...
- Tumors less than 5 cm in maximum dimension at enrollment
- Tumors with ≤25% increase in size (on any dimension) on MRI 4-8 weeks post-radiotherapy remain eligible for study
- Tumors with \>25% increase in size on post-radiation imaging may be reassessed with repeat MRI in 4-6 weeks, and are eligible if tumor size is subsequently ≤ 25% increased compared with pre-irradiation MRI.
- Tumors with sizes between 5 and 5.5 cm are eligible if the tumor was surgically debulked
- Measurable disease on at least 2 dimensions on MRI
- Age 12 months to 25 years
- Functional score (Karnofsky/Lansky) ≥ 50 expected at infusion (≥60 for cohort 2) Procurement
- Patients who are pregnant or breast feeding
- Any patient with other risk factors for whom administration of investigational agent is deemed not in the patient's best interest, in the opinion of the investigator. Treatment Inclusion Criteria Cohort 1:
- Histologically confirmed, GD2-expressing newly diagnosed DMG/HGG (including pontine) or confirmation of H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available. Newly diagnosed is defined as prior...
- Tumors less than 5 cm in maximum dimension at enrollment
- Tumors with ≤25% increase in size (on any dimension) on MRI 4-8 weeks post-radiotherapy remain eligible for study
- Tumors with \>25% increase in size on post-radiation imaging may be reassessed with repeat MRI in 4-6 weeks, and are eligible if tumor size is subsequently ≤ 25% increased compared pre-irradiation MRI
- Tumors with sizes between 5 and 5.5 cm are eligible if the tumor was surgically debulked
- Measurable disease on at least 2 dimensions on MRI
- Central line (PICC or other) and Ommaya reservoir or VP shunt in place or planned to be placed. Central line/PICC may be omitted for cycles that do not include lymphodepletion
- Age 12 months to 25 years
- Functional score (Karnofsky/Lansky) ≥ 50 (≥60 for cohort 2)
- Patients must have completed standard of care radiation therapy at least 4 weeks prior to administration of investigational agent. If bevacizumab was administered for management of radiation necrosis, therapy must be...
- Stable neurologic exam for 7 days prior to enrollment
- Stable or decreasing dose of steroids (max. allowable dose of dexamethasone is 0.1 mg/kg/day over the past 7 days prior to infusion of investigational therapy)
- Organ function:
- ANC \> 1000 cells/ul
- Platelet count \> 100,000 cells/ul
- Total bilirubin \< 1.5x ULN
- ALT and AST \< 5x ULN
- Serum creatinine or kidney within 2x ULN for age Treatment Exclusion Criteria
- Patients who received any other forms of immunotherapy ≤ 42 days before administration of investigational agent
- Patients who received colony-stimulating factors within 14 days prior to administration of lymphodepletion
- Patients receiving any concurrent anti-cancer therapy (treatment must occur at least three half-lives following prior anti-cancer therapy)
- Patients who are pregnant or breast feeding
- Any patient with other risk factors for whom administration of investigational agent is deemed not in the patient's best interest, in the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 months to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. 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.