Pilot Study of NKG2D CAR-T in Treating Patients With Recurrent Glioblastoma

Not Applicable

• Conditions: Recurrent Glioblastoma
• Interventions: Biological: NKG2D CAR-T

• Registration Number: NCT04717999
• Lead Sponsor: UWELL Biopharma

Brief Summary

This is a pilot phase I study to evaluate the safety and efficacy of NKG2D CAR-T cell therapy in patients with relapsed and/or refractory glioblastoma

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-16
• Study First Submitted QC: 2021-01-16
• Last Update Submitted: 2021-01-16
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-22
• Study Start: 2021-09-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Histologically confirmed glioblastoma multiforme (GBM) and are at first or second relapse.
• Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,000 cells/µl, platelets ≥ 125,000 cells/µl
• No active infection of HIV, HTLV and Syphilis
• Adequate renal function
• Adequate hepatic function
• Adequate cardiac function
• Adequate venous access for apheresis, and no other contraindications for leukapheresis
• Voluntary informed consent is given.

Exclusion Criteria

• Pregnant or lactating women.
• Uncontrolled active infection.
• History of hepatitis B or hepatitis C infection.
• Previously treatment with any gene therapy products or cell therapy product in past 28 days.
• Cannot undergo MRI with contrast or SPECT/CT
• HIV infection.
• Have autoimmune disorders
• Have active infection or inflammatory disorders
• Prescreening test results in expansion rate less than 5 folds
• An allergy to gentamycin and/or streptomycin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UWN2D CAR-T	NKG2D CAR-T	-

Primary Outcome Measures

Name	Time	Method
Number of Participants who experience a Dose-Limiting Toxicity (DLT)	2 years	Defined as the dose safely administered Intratumoral for the treatment of patients with GBM

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	1 year	Defined as the proportion of subjects with overall response of either complete response (CR) or partial response (PR)
Progression-free survival	1 year	Defined as date of the first NKG2D CAR-T infusion to the date of disease progression per RANO Response Criteria or death