This first-in-human clinical study aims to evaluate the safety and feasibility of locally delivered, allogeneic γδ T cells (genetically edited with ARIH1 and BCL11b knockout, designated ABOUT γδT cells) in patients with glioblastoma multiforme (GBM). The engineered effector cells are delivered via localized administration to selectively target and eliminate residual GBM cells. ABOUT: ARIH1 and BCL11b knockOUT γδ T cells.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Allogeneic γδ T cells genetically edited to knockout the ARIH1 and BCL11b genes.
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGZhengzhou Second Hospital
Zhengzhou, Henan, China
RECRUITINGHenan Academy of Innovations in Medical Science
Zhengzhou, Henan, China
RECRUITINGIncidence of Adverse Events (AEs)
Defined as the incidence of ≥ Grade 3-4 adverse events related to ABOUT γδT cells according to common terminology criteria for adverse events (CTCAE) v6.0.
Time frame: 3 months following ABOUT γδT cells administration
Incidence of Dose-Limiting Toxicities (DLTs)
Defined as events attributable to ABOUT γδT cells infusion within 28 days post-infusion. Grade 3-4 acute graft-versus-host disease (GvHD) according to the Mount Sinai Acute GvHD International Consortium criteria; Grade 3 or higher cytokine release syndrome (CRS) lasting more than 2 weeks, according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria; Any ABOUT γδT cells-related AE requiring intubation; Grade 4 non-hematologic toxicities.
Time frame: 28 days following initial treatment with ABOUT γδT cells
Objective Response Rate (ORR)
According to modified RANO criteria, ORR is defined as proportion of subjects with confirmed CR and PR.
Time frame: 3 months following ABOUT γδT cells administration
Duration of response (DOR)
According to modified RANO criteria, DOR is defined as time from the date when a response of confirmed CR/PR is first met to the date of confirmed disease progression or death.
Time frame: 3 months following ABOUT γδT cells administration
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