Chimeric Switch Receptor Modified T Cells for Patients With PD-L1+ Recurrent or Metastatic Malignant Tumors
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|ClinicalTrials.gov Identifier: NCT02930967|
Recruitment Status : Recruiting
First Posted : October 12, 2016
Last Update Posted : October 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Recurrent PD-L1+ Malignant Tumors Metastatic PD-L1+ Malignant Tumors||Biological: autologous CSR T||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 Chimeric Switch Receptor Modified T Cells in Patients With Recurrent or Metastatic Malignant Tumors|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2019|
Experimental: CSR T cells
A dose escalation clinical study aimed to assess the safety and efficacy of CSR T cells in patients with PD-L1 positive tumors.
CSR T dosage ranging from: 5×10^4 /kg to 1×10^7 /kg will be tested.
Biological: autologous CSR T
Patients will be received a three-day regimen of chemotherapy consisting of cyclophosphamide aimed to deplete the lymphocytes. 1 to 4 days after lymphodepletion, a prescribed dose of CSR T cells will be intravenously infused to patient in a three-day split-dose regimen (day0,10%; day1, 30%; day2, 60%).
- Safety as assessed by incidents of treatment related adverse events as assessed by CTCAE V4.0. [ Time Frame: 2 years ]safety of infusion of autologous CSR T cells with cyclophosphamide as lymphodepleting chemotherapy
- treatment response rate of CSR T cell infusion [ 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 [ Time Frame: 6 months ]
- proliferation of CSR T cells in patients [ Time Frame: 2 years ]
- Persistence of CSR T cells in patients [ Time Frame: 2 years ]
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): NCT02930967
|Contact: Shidong Wei, MDemail@example.com|
|China Meitan General Hospital||Recruiting|
|Beijing, China, 100028|
|Contact: Shidong Wei, MD +86-13146634751 firstname.lastname@example.org|
|Principal Investigator:||Jinwen Sun, MD||China Meitan General Hospital|