Pilot Study of NKG2D CAR-T in Treating Patients With Recurrent Glioblastoma
Pilot Study of UWNKG2D CAR-T in Treating Patients With Recurrent Glioblastoma
1 other identifier
interventional
20
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJanuary 22, 2021
January 1, 2021
2.1 years
January 16, 2021
January 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Overall Response Rate
1 year
Progression-free survival
1 year
Study Arms (1)
UWN2D CAR-T
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UWELL Biopharmalead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2021
First Posted
January 22, 2021
Study Start
September 1, 2021
Primary Completion
September 30, 2023
Study Completion
December 31, 2023
Last Updated
January 22, 2021
Record last verified: 2021-01