Recurrent Glioblastoma Clinical Trial
Official title:
B7-H3-Targeted Chimeric Antigen Receptor (CAR) T Cells in Treating Patients With Recurrent or Refractory Glioblastoma
This is a randomized, parallel-arm, phase I/II study to evaluate the safety and efficacy of B7-H3 CAR-T in between Temozolomide cycles comparing to Temozolomide alone in treating patients with glioblastoma that has come back or does not respond to the standard treatment. The antigen B7-H3 is highly expressed in glioblastoma of a subset of patients. B7-H3 CAR-T, made from isolated patient peripheral blood mononuclear cells, can specifically attack patient glioblastoma cells that expressing B7-H3.
Background - B7-H3 is expressed in 70% of patients with glioblastoma - B7-H3 is not expressed in normal tissues especially not in central nervous system. Therefore, it is an attractive GBM target for CAR-T therapy - The investigators constructed a retroviral vector encoding a chimeric antigen receptor (CAR) targeting B7-H3, which can mediate CAR transfer into patient T cells with high efficiency. Objectives - To evaluate the safety and tolerability intratumoral/intracerebroventricular injection of B7-H3 CAR-T when used in between Temozolomide cycles - To compare the overall survival (OS) and progression-free survival (PFS) of R/R GBM patients treated with B7-H3 CAR-T in between Temozolomide cycles vs Temozolomide alone - To access the pharmacokinetics and pharmacodynamics of B7-H3 CAR-T in between Temozolomide cycles Design - Experimental group: Patients autologous T cells are activated and transduced with retrovirus containing B7-H3 CAR. CAR-T cells are expanded ex vivo and infused back to patients via intratumoral or intracerebroventricular injection through an Ommaya catheter. 3 injections of CAR-T are planned at two different doses with 1-2 weeks intervals. The CAR-T injections occur in between Temozolomide (TMZ) cycles. Temozolomide treatment during the cycles of CAR-T injections will be stopped and resumed next cycle. Patients may receive additional CAR-T cycles at the discretion of the principal investigator and oncologist. - Control group: Patients will receive regular cycles of Temozolomide treatment with 5 days of treatment and 23 days of interval. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05577091 -
Tris-CAR-T Cell Therapy for Recurrent Glioblastoma
|
Phase 1 | |
Recruiting |
NCT05284643 -
Spectroscopic MRI, Proton Therapy, and Avastin for Recurrent Glioblastoma
|
N/A | |
Recruiting |
NCT05039281 -
Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT04988750 -
Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM Patients
|
N/A | |
Recruiting |
NCT06058988 -
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
|
Phase 2 | |
Completed |
NCT00503204 -
Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour
|
Phase 1 | |
Completed |
NCT03216499 -
HIF-2 Alpha Inhibitor PT2385 in Treating Patients With Recurrent Glioblastoma
|
Phase 2 | |
Not yet recruiting |
NCT04717999 -
Pilot Study of NKG2D CAR-T in Treating Patients With Recurrent Glioblastoma
|
N/A | |
Not yet recruiting |
NCT05540275 -
Tislelizumab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for Bevacizumab Refractory Recurrent Glioblastoma
|
Phase 2 | |
Recruiting |
NCT04528680 -
Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma
|
Phase 1/Phase 2 | |
Completed |
NCT04044937 -
Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms
|
Phase 2 | |
Recruiting |
NCT04888611 -
Neoadjuvant PD-1 Antibody Alone or Combined With DC Vaccines for Recurrent Glioblastoma
|
Phase 2 | |
Completed |
NCT00390299 -
Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
|
Phase 1 | |
Recruiting |
NCT05463848 -
Surgical Pembro +/- Olaparib w TMZ for rGBM
|
Phase 2 | |
Active, not recruiting |
NCT04479241 -
LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma
|
Phase 2 | |
Active, not recruiting |
NCT00777153 -
Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma
|
Phase 3 | |
Withdrawn |
NCT05017610 -
Inducing a Hypothyroxinemic State in Patients With Recurrent Glioblastoma or Gliosarcoma
|
Early Phase 1 | |
Recruiting |
NCT04323046 -
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
|
Phase 1 | |
Active, not recruiting |
NCT05324501 -
A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma
|
Phase 1 | |
Withdrawn |
NCT05666349 -
Reirradiation and Niraparib in Patients With Recurrent Glioblastoma
|
Phase 1 |