About this trial

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.

Eligibility criteria

Qualifiers

Male or female, age 18-70 years old (both ends included)

At least one evaluable lesion with previous biopsy or pathohistologic confirmation of glioblastoma (WHO grade IV), with imaging suggestive of continued progression or recurrence after comprehensive treatment

Karnofsky Performance Status (KPS) ≥ 60%

Life expectancy > 4 weeks

Disqualifiers

Active hepatitis B or C virus, HIV infection, or other untreated active infection

Pregnant and lactating women

Participants with organ failure

Participants with a chronic disease requiring immunologic or hormonal therapy

Trial design

Treatments tested in this trial

  • Allogeneic γδ T (ABOUT) cells

Treatment groups

18 Participants
are divided into 3 treatment groups

Locations

3
Peking University Third Hospital100191, BeijingBeijing Municipality, China
Henan Academy of Innovations in Medical Science451162, ZhengzhouHenan, China
Zhengzhou Second Hospital450052, ZhengzhouHenan, China

Sponsors and collaborators

Peking University Third Hospital

Lead sponsor

Peking University

Collaborator

Changping Laboratory

Collaborator