A Phase 1 interventional study of Anti-PD-L1 CSR T cells and Cyclophosphamide in Glioblastoma Multiforme, sponsored by Beijing Sanbo Brain Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-10-19.
Sponsored by Beijing Sanbo Brain Hospital · Phase 1, Interventional, and Treatment
CAR T cell immunotherapy has achieved great success in CD19+ B-cell malignancies. Whether this new generation of cell-based immunotherapy can be applied to solid tumors remain to be investigated, partly due to hostile immune-suppressive tumor microenvironment which favors tumor growth but not immune system. Signaling pathway of programmed death 1 (PD-1) and its ligand PD-L1 plays an important role in suppressing immune response against tumors. PD-L1 is over-expressed in 88% of glioblastoma.
We constructed a chimeric switch receptor (CSR) containing the extracellular domain of PD1 fused to the transmembrane and cytoplasmic domain of the costimulatory molecule CD28. CSR modified T cells are able to recognize PD-L1-expressing tumor cells and transduce signals to activate T cells, which results in tumor killing. A truncated EGFR (tEGFR) which lacks of the ligand binding domain and cytoplasmic kinase domain of wildtype EGFR is incorporated into the CSR vector and is used for in vivo tracking and ablation of CSR T cells when necessary. This pilot study is to determine the safety and efficacy of autologous CSR T cells in patients with recurrent glioblastoma.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's planned enrollment of 20 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Beijing Sanbo Brain Hospital is the lead sponsor of 17 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Patients will receive lymphodepletion chemotherapy consisting of fludarabine and cyclophosphamide, followed by intravenous infusion of autologous anti- PD-L1 CSR 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-PD-L1 CSR T cells · Drug: Cyclophosphamide · Drug: Fludarabine
Prescribed CSR T cells are infused intravenously to patients in a three-day split-dose regimen（day0,10%; day1, 30%; day2, 60%）.
250 mg/m\^2, d1-3
25mg/m\^2, d1-3
Number of Adverse Events related to CSR T cell infusion
Time frame: 2 years
Treatment Responses Rate
Defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease(SD), or progressive disease (PD).
Time frame: 4 weeks
Overall Survival Rate
Time frame: 2 years
Progression-free Survival Rate
Time frame: 6 months
Persistence of CSR T cells in patients
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Beijing Sanbo Brain Hospital