Status:
UNKNOWN
Pilot Study of NKG2D CAR-T in Treating Patients With Recurrent Glioblastoma
Lead Sponsor:
UWELL Biopharma
Conditions:
Recurrent Glioblastoma
Eligibility:
All Genders
20-70 years
Phase:
NA
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04717999
Start Date
September 1 2021
End Date
December 31 2023
Last Update
January 22 2021
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