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

NCT ID: NCT04717999

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Recurrent Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UWN2D CAR-T

Group Type EXPERIMENTAL

NKG2D CAR-T

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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UWN2D

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UWELL Biopharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Cheng-Yi Kuo, PhD

Role: CONTACT

+886-2-26972200 ext. 202

Other Identifiers

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UBP-P02-3001-GBM

Identifier Type: -

Identifier Source: org_study_id

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