Status:
RECRUITING
C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Faris Foundation
Conditions:
Diffuse Intrinsic Pontine Glioma
High Grade Glioma
Eligibility:
All Genders
12-22 years
Phase:
PHASE1
Brief Summary
In this study, there are two treatment groups called Cohort 1 and Cohort 2. Cohort 1 is for patients with diffuse midline glioma, high grade glioma, diffuse intrinsic pontine glioma, medulloblastoma, ...
Detailed Description
To prepare the brain cancer specific GD2-C7R T cells, research staff will take some blood from the patient. The researchers will grow the GD2.C7R T cells by infecting the T cells with a retroviral vec...
Eligibility Criteria
Inclusion
- 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 to radiographic progression or recurrence.
- OR
- Histologically confirmed, GD2-expressing recurrent, refractory, or progressive DMG/HGG (except pontine) or confirmation of positive H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available.
- OR
- Recurrent, refractory, or progressive high-grade CNS tumor with confirmed GD2-expression. Examples include: medulloblastoma "CNS embryonal tumors, AT/RT, ependymal tumors, diffuse gliomas or glioneuronal tumors.
- Cohort 2:
- Recurrent, refractory, or progressive pontine HGG with confirmed GD2-expression or H3K27-altered DMG
- 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 22 years
- Functional score (Karnofsky/Lansky) ≥ 50 expected at infusion (≥60 for cohort 2)
- Procurement
Exclusion
- 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 to radiographic progression or recurrence.
- OR
- Histologically confirmed, GD2-expressing recurrent, refractory, or progressive DMG/HGG (except pontine) or confirmation of positive H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available.
- OR
- Recurrent, refractory, or progressive high -grade CNS tumor with confirmed GD2-expression. Examples include: medulloblastoma, CNS embryonal tumors, AT/RT, ependymal tumors, diffuse gliomas, or glioneuronal tumors.
- Cohort 2:
- Recurrent, refractory, or progressive pontine HGG with confirmed GD2-expression or H3K27-altered for DMG.
- 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
- Age 12 months to 22 years
- Functional score (Karnofsky/Lansky) ≥ 50 (≥60 for cohort 2)
- Patients must have completed radiation therapy at least 4 weeks prior to administration of investigational agent. Radiation therapy and (If applicable) bevacizumab treatment for radiation necrosis must be completed at least 4 weeks prior to administration of investigational agent.
- 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 (it is preferable for patients to stop any concurrent anti-cancer therapy at least three half-lives prior to treatment)
- 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.
Key Trial Info
Start Date :
February 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2041
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04099797
Start Date
February 3 2020
End Date
February 1 2041
Last Update
September 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Texas Children's Hospital
Houston, Texas, United States, 77030