BENITIONSClinical Trial Intelligence

Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma

1상 진행 중(모집 완료) NCT02208362

대상 질환Recurrent Glioblastoma, Recurrent Malignant Glioma, Recurrent WHO Grade II Glioma, Recurrent WHO Grade III Glioma
임상 단계1상
스폰서City of Hope Medical Center
상태진행 중(모집 완료)
참여자 수65 명
중재(약물)Arm 1: IL13Ra2-specific CAR Tcm cells, Arm 2: IL13Ra2-specific CAR Tcm cells, Arm 3: IL13Ra2-specific CAR Tcm cells, Arm 4: IL13Ra2-specific CAR Tcm cells, Arm 5: IL13Ra2-specific CAR Tn/mem cells
시작일2015년 5월 18일
완료일2021년 2월 8일
결과 공개일2024년 10월 30일

요약

This phase I trial studies the side effects and best dose of genetically modified T-cell immunotherapy in treating patients with malignant glioma that has come back (recurrent) or has not responded to therapy (refractory). A T cell is a type of immune cell that can recognize and kill abnormal cells in the body. T cells are taken from the patient's blood and a modified gene is placed into them in the laboratory and this may help them recognize and kill glioma cells. Genetically modified T-cells may also help the body build an immune response against the tumor cells.

Number of Participants With Grade 3 or Higher Toxicity Related to CAR T Cells

An average of 11 months · Participants

Arm 1 Dose Schedule 10 Participants
Arm 2 Dose Schedule 10 Participants
Arm 2 Dose Schedule 20 Participants
Arm 2 Dose Schedule 30 Participants
Arm 3 Dose Schedule 10 Participants
Arm 3 Dose Schedule 20 Participants

Number of Participants Experiencing a Dose Limiting Toxicity (DLT)

Up to 1 week following the last course, up to a total of 4 weeks (not including optional courses 4-6) · Participants

Arm 1 Dose Schedule 10 Participants
Arm 2 Dose Schedule 10 Participants
Arm 2 Dose Schedule 20 Participants
Arm 2 Dose Schedule 30 Participants
Arm 3 Dose Schedule 10 Participants
Arm 3 Dose Schedule 20 Participants

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