IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Adult Glioblastoma

ConditionsGlioblastoma Multiforme Glioblastoma

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-80

SponsorUniversity of Florida

About this trial

This is a phase I study to assess the safety and feasibility of IL-8 receptor modified patient-derived activated CD70 CAR T cell therapy in CD70+ adult glioblastoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Newly-diagnosed de novo GBM based on the absence of previous history of brain tumor (WHO Grade IV glioma) by histopathology or molecular studies. (secondary GBM not eligible)

The tumor must have a supratentorial component

CD70 positive (≥5%, 1+)

Disqualifiers

Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3years. (In situ cancer are permissible)

Metastases detected below the tentorium or beyond the cranial vault

Leptomeningeal disease beyond the cranial vault. (Focal, adjacent and leptomeningeal involvement is allowable at the discretion of the PI).

Recurrent or multifocal malignant gliomas.

Trial design

Design model

Single group

Treatments tested in this trial

Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells
Biological/Vaccine
Single dose of 8R-70CAR T cells administered IV

Treatment groups

39 Participants

are divided into 1 treatment group

Group A: 8R-70CAR T cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety of 8R-70CAR T-cell therapy in adult patients with de novo CD70+ GBM

Defined as ≤ 1 DLT out of 6 patients is observed at the 1x10\^8 cells/Kg dose. Dose-Limiting toxicity (DLT) will be defined as any adverse event attributable (possible, probable, or definite) to the administration of 8R-70CAR T cells and occurring from the time of infusion through 28 days post-infusion.

Time frame

28 days post-infusion

Feasibility of 8R-70CAR T-cell therapy in adult patients with de novo CD70+ GBM

Feasibility will be defined as the ability to infuse 8R-70CAR T-cell safely in 66.7 % of enrolled patients (patients who signed consent and were deemed eligible for the study).

Time frame

10 weeks

Sponsors and contacts

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

University of Florida

Lead sponsor

AM Rosen Foundation

Collaborator

Source ClinicalTrials.gov

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