Recurrent Glioblastoma
Conditions
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
Interventions
BIOLOGICALNKG2D 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.
Sponsors
UWELL Biopharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who experience a Dose-Limiting Toxicity (DLT) | 2 years | Defined as the dose safely administered Intratumoral for the treatment of patients with GBM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | 1 year | Defined as the proportion of subjects with overall response of either complete response (CR) or partial response (PR) |
| Progression-free survival | 1 year | Defined as date of the first NKG2D CAR-T infusion to the date of disease progression per RANO Response Criteria or death |
Contacts
Primary ContactCheng-Yi Kuo, PhD
Outcome results
None listed