Pilot Study of Autologous Anti-EGFRvIII CAR T Cells in Recurrent Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT02844062|
Recruitment Status : Unknown
Verified July 2016 by Beijing Sanbo Brain Hospital.
Recruitment status was: Recruiting
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Biological: anti-EGFRvIII CAR T cells Drug: cyclophosphamide Drug: Fludarabine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety and Efficacy Study of Autologous Chimeric Antigen Receptor Engineered T Cells Redirected to EGFRvIII in Patients With Recurrent Glioblastoma Multiforme|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2019|
Experimental: anti-EGFRvIII CAR T cells
Patients will receive lymphodepletion chemotherapy consisting of fludarabine and cyclophosphamide, followed by intravenous infusion of autologous anti-EGFRvIII CAR T cells. A standard 3+3 escalation approach will be used to obtain the safe dosage of CAR T cells. The tested CAR T cell dosage ranges from 5×10^4 /kg to 1×10^7 /kg
Biological: anti-EGFRvIII CAR T cells
CAR T cells are infused intravenously to patients in a three-day split-dose regimen（day0,10%; day1, 30%; day2, 60%）with a total targeted dose.
250 mg/m^2 d1-3
- Safety of infusion of autologous anti-EGFRvIII CAR T cells with cyclophosphamide and fludarabine as lymphodepleting chemotherapy in patients with recurrent glioblastoma using the NCI CTCAE V4.0 criteria. [ Time Frame: 2 years ]incidents of treatment related adverse events as assessed by CTCAE V4.0.
- Treatment Responses Rate [ Time Frame: 4 weeks ]defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD).
- Overall Survival Rate [ Time Frame: 2 years ]
- Progression-free Survival Rate [ Time Frame: 2 years ]
- Persistence of CAR T cells in patients [ Time Frame: 2 years ]
- Proliferation of CAR T cells in patients [ Time Frame: 2 years ]CAR T cell proliferation in patients is monitored by flow or qPCR
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844062
|Contact: Zhixiong Lin, MDfirstname.lastname@example.org|
|Sanbo Brain Hospital Capital Medical University||Recruiting|
|Beijing, China, 100093|
|Contact: Zhixiong Lin, MD +86-10-13905918963 email@example.com|
|Principal Investigator:||Zhixiong Lin, MD||Sanbo Brain Hospital Capital Medical University|