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

UWELL Biopharma

Status: Unknown

Conditions: Recurrent Glioblastoma

Treatments: Biological: NKG2D CAR-T

Study type: Interventional

Funder types: Industry

Identifiers

NCT04717999

UBP-P02-3001-GBM

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

UWN2D CAR-T

Experimental group

Treatment:

Biological: NKG2D CAR-T