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

Recurrent Glioblastoma Clinical Trial

Official title:

Pilot Study of UWNKG2D CAR-T in Treating Patients With Recurrent Glioblastoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04717999
• Other study ID #: UBP-P02-3001-GBM
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2021
• Source: UWELL Biopharma
• Contact: Cheng-Yi Kuo, PhD
• Phone: +886-2-26972200
• Email: jerry.kuo[@]uwell.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Recurrent Glioblastoma

Intervention

Biological:
• NKG2D CAR-T
The NKG2D CAR-T will be administrated via intracerebroventricular injection through an Ommaya catheter. Standard treatments such as temozolomide will be stopped during the infusion of NKG2D CAR-T.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UWELL Biopharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who experience a Dose-Limiting Toxicity (DLT)	Defined as the dose safely administered Intratumoral for the treatment of patients with GBM	2 years
Secondary	Overall Response Rate	Defined as the proportion of subjects with overall response of either complete response (CR) or partial response (PR)	1 year
Secondary	Progression-free survival	Defined as date of the first NKG2D CAR-T infusion to the date of disease progression per RANO Response Criteria or death	1 year