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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 20 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04717999
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 UWELL Biopharma
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Unknown status
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Recurrent Glioblastoma
Arms & Interventions

Arms

Experimental: UWN2D CAR-T

Interventions

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Cheng-Yi Kuo, PhD

[email protected]

+886-2-26972200

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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