Recurrent GlioblastomaNCT04717999
Pilot Study of NKG2D CAR-T in Treating Patients With Recurrent Glioblastoma
A study testing NKG2D CAR-T in people with Recurrent Glioblastoma, run by UWELL Biopharma.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- NKG2D CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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
- Conditions
- Recurrent Glioblastoma
- Being tested
- NKG2D CAR-T
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKG2D CAR-TBiological
Also called UWN2D
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.
| Study group | Role | What they receive |
|---|---|---|
| UWN2D CAR-T | Experimental | Not described Receives: Biological: NKG2D CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who experience a Dose-Limiting Toxicity (DLT)
Defined as the dose safely administered Intratumoral for the treatment of patients with GBM
Measured: 2 years
Secondary outcomes (2)
Overall Response Rate
Defined as the proportion of subjects with overall response of either complete response (CR) or partial response (PR)
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Sep 2021 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UWELL Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717999
- Sponsor's protocol ID
- UBP-P02-3001-GBM
- Status last verified
- Jan 2021
- First submitted
- 16 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of UWNKG2D CAR-T in Treating Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT04717999
- Acronym / sponsor ID
- UBP-P02-3001-GBM
- Conditions
- Recurrent Glioblastoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- UWELL BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UWN2D CAR-T | Experimental | Biological: NKG2D CAR-T |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NKG2D CAR-TAlso: UWN2DThe 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. | Biological | UWN2D CAR-T |
Primary outcome
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 secondary outcomes
Overall Response Rate
Time frame: 1 year
Progression-free survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing NKG2D CAR-T in people with Recurrent Glioblastoma, run by UWELL Biopharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng-Yi Kuo, PhD (+886-2-26972200 ext. 202, jerry.kuo@uwell.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who experience a Dose-Limiting Toxicity (DLT) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.