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

Primary Purpose

Recurrent Glioblastoma

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

NKG2D CAR-T

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UWN2D CAR-T

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants who experience a Dose-Limiting Toxicity (DLT)

Defined as the dose safely administered Intratumoral for the treatment of patients with GBM

Secondary Outcome Measures

Overall Response Rate

Defined as the proportion of subjects with overall response of either complete response (CR) or partial response (PR)

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

Full Information

NCT ID

NCT04717999

First Posted

January 16, 2021

Last Updated

January 16, 2021

Sponsor

UWELL Biopharma

1. Study Identification

Unique Protocol Identification Number

NCT04717999

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2021 (Anticipated)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UWELL Biopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

UWN2D CAR-T

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

NKG2D CAR-T

Other Intervention Name(s)

UWN2D

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants who experience a Dose-Limiting Toxicity (DLT)

Description

Defined as the dose safely administered Intratumoral for the treatment of patients with GBM

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall Response Rate

Description

Defined as the proportion of subjects with overall response of either complete response (CR) or partial response (PR)

Time Frame

1 year

Title

Progression-free survival

Description

Defined as date of the first NKG2D CAR-T infusion to the date of disease progression per RANO Response Criteria or death

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cheng-Yi Kuo, PhD

Phone

+886-2-26972200

Ext

202

jerry.kuo@uwell.com.tw

12. IPD Sharing Statement

Learn more about this trial

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

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