Clinical trialPhase 1Unknown
Chimeric Switch Receptor Modified T Cells for Patients With PD-L1+ Recurrent or Metastatic Malignant Tumors
A Safety and Efficacy Study of Chimeric Switch Receptor Modified T Cells in Patients With Recurrent or Metastatic Malignant Tumors
- Outcome
- Outcome unknown
- Cell product
- Other cell therapies
In this single-arm, open-label, one center, dose escalation clinical study, the main purpose is to determine the safety and efficacy of infusion of autologous Chimeric Switch Receptor modified T cells (CSR T) in adult patients with PD-L1 p…
- Cell source
- Autologous
Biological: autologous CSR T
- Lymphodepletion
- Stated
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%;
- Phase
- Phase 1
- Status
- Unknown
- Study type
- Interventional
- Start
- August 2016
- Listed end
- August 2019
- Enrollment
- 20 participants
- Sites
- 1
- Primary outcomes
- Safety as assessed by incidents of treatment related adverse events as assessed by CTCAE V4.0.
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 12 October 2016
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Source text
Brief summary public domain (ClinicalTrials.gov)
A Chimeric Switch Receptor, which was constructed by fusing the PD1 extracellular ligand binding domain to the CD28 intracellular costimulatory domain, was designed to target PD-L 1 positive tumors . In this single-arm, open-label, one center, dose escalation clinical study, the main purpose is to determine the safety and efficacy of infusion of autologous Chimeric Switch Receptor modified T cells (CSR T) in adult patients with PD-L1 positive, recurrent or metastatic malignant tumors.
Intervention public domain (ClinicalTrials.gov)
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%).
Arm public domain (ClinicalTrials.gov)
CSR T cells (experimental): 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.