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Allogeneic γδT Cells in Glioblastoma

ConditionsGlioblastoma (GBM)Glioblastoma Multiforme (GBM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking University Third Hospital

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Allogeneic γδ T (ABOUT) cells

    Drug

    Allogeneic γδ T cells genetically edited to knockout the ARIH1 and BCL11b genes.

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: Low doseExperimental treatment 1 intervention
Group B: Medium doseExperimental treatment 1 intervention
Group C: High doseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence 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
2

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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Third Hospital

Lead sponsor

Peking University

Collaborator

Changping Laboratory

Collaborator

Source ClinicalTrials.gov
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