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

January 16, 2021 updated by: UWELL Biopharma

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: UWN2D CAR-T
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.
Other Names:
  • UWN2D

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UWELL Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2021

Primary Completion (ANTICIPATED)

September 30, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

January 16, 2021

First Submitted That Met QC Criteria

January 16, 2021

First Posted (ACTUAL)

January 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 16, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBP-P02-3001-GBM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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