Back to resultsDC1s-CTL Cellular Therapy for Renal Cell Carcinoma
Primary Purpose
Renal Cell Carcinoma
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
DC1-CTL
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring dendritic cells, cytotoxic T lymphocyte, DC vaccine
Eligibility Criteria
Inclusion Criteria:
Patients with histologically confirmed stage III-IV renal malignancies; The patient underwent radical operation of RCC within 8 weeks before enrollment; Must have normal marrow hematopoiesis function as defined below: Hemoglobin≥90g/L, WBC>4000/mm3, Absolute Neutrophil Count (ANC)≥1500/µL, Platelet≥ 100,000/µL, Must have normal important organ function as defined below: Total bilirubin≤1.5 x institutional upper limit of normal(ULN), AST(SGOT) and ALT(SGPT)≤2.5x ULN , ALP≤1.5x ULN; BUN and Creatinine <1.5x ULN, Creatinine clearance ≥80mL/min.
life expectancy≥3 months; No other serious heart, liver and kidney organ dysfunction; Quality of life score (Karnofsky performance score) ≥60; Patients must be able to understand and be willing to sign a written informed consent document.
Exclusion Criteria:
Prior allergic reaction or hypersensitivity to cytokines (eg.IL-2); Patients with systemic or local infection requiring anti-infectious treatment; Patients currently treated with systemic immunosuppressive agents, including steroids, Patients with active autoimmune disease or history of transplantation requiring steroid treatment; Tested positive for HIV; Pregnant or lactating women Patients with important organ dysfunction; Any reason that, in the opinion of the investigator, contraindicates that the patient participates in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
dendritic cell vaccine
Arm Description
DC1-CTL cellular therapy
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Our primary objective is to evaluate whether our cellular therapy regimen is safe.
Secondary Outcome Measures
G250 mRNA figures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02787915
Brief Title
DC1s-CTL Cellular Therapy for Renal Cell Carcinoma
Official Title
DC1s-CTL Cell Therapy to Treat Patients With Renal Cell Carcinoma After Radical Resection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuzhou Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This trial is to evaluate the safety and effectiveness of autologous type-1 polarized dendritic cell vaccines (patients' autologous DC1s loaded with multiple antigens CTL epitope peptide complexes), after radical resection for patients with stage III-IV renal cell carcinoma. Autologous cytotoxic of T lymphocytes (CTL) induced by type-1 polarized dendritic cells (DC1) loaded with MAGE-3/MAGE-4/survivin/ her2 /COX-2 CTL epitope peptides .
Detailed Description
All participants judged to have RCC and considered able to conduct apheresis. Immunotherapy regimen will include subcutaneous injection (3million cells) DC1 vaccines and intravenous infusion CTL cells. On day 0,participants conduct apheresis for 50-60ml. PBMCs were separated from paiticipants by density gradient centrifugation. The adherent cells were initiated into DC followed by the particular combination of cytokines to promote DC type-1 polarization. On day 6, the synthetic CTL epitope peptides were added into the culture for autologous DCs for another 24h. Then one half of DC1s were resuspended in 1ml normal saline for clinical multi-point injection near lymph nodes. The remaining half were cocultured with autologous T cells for another 7 days to induce antigen-specific CTL cells. The applied TAAs included MAGE-3/ MAGE-4/ survivin/ her2 /ect. On day 14, after quality inspection qualified, CTL cells were harvested and resuspended in 100ml normal saline and 2% autologous plasma for clinical intravenous infusion, once a day for 3 days. In order to avoid overlap between experimental immunotherapy and potential adjuvant chemotherapy, chemotherapy may start at least 2 weeks after completion of the cycle of immunotherapy. The 2nd cycle of immunotherapy may start at least 4weeks after the completion of chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
dendritic cells, cytotoxic T lymphocyte, DC vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dendritic cell vaccine
Arm Type
Experimental
Arm Description
DC1-CTL cellular therapy
Intervention Type
Biological
Intervention Name(s)
DC1-CTL
Intervention Description
Autologous cytotoxic of T lymphocytes (CTL) were induced by type-1 polarized dendritic cells (DC1) loaded with MAGE-3/MAGE-4/survivin/ her2 /COX-2 CTL epitope peptides .
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
Our primary objective is to evaluate whether our cellular therapy regimen is safe.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
G250 mRNA figures
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
T cell subsets figures
Time Frame
12 weeks
Title
Serum cytokine secretion figures
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with histologically confirmed stage III-IV renal malignancies; The patient underwent radical operation of RCC within 8 weeks before enrollment; Must have normal marrow hematopoiesis function as defined below: Hemoglobin≥90g/L, WBC>4000/mm3, Absolute Neutrophil Count (ANC)≥1500/µL, Platelet≥ 100,000/µL, Must have normal important organ function as defined below: Total bilirubin≤1.5 x institutional upper limit of normal(ULN), AST(SGOT) and ALT(SGPT)≤2.5x ULN , ALP≤1.5x ULN; BUN and Creatinine <1.5x ULN, Creatinine clearance ≥80mL/min.
life expectancy≥3 months; No other serious heart, liver and kidney organ dysfunction; Quality of life score (Karnofsky performance score) ≥60; Patients must be able to understand and be willing to sign a written informed consent document.
Exclusion Criteria:
Prior allergic reaction or hypersensitivity to cytokines (eg.IL-2); Patients with systemic or local infection requiring anti-infectious treatment; Patients currently treated with systemic immunosuppressive agents, including steroids, Patients with active autoimmune disease or history of transplantation requiring steroid treatment; Tested positive for HIV; Pregnant or lactating women Patients with important organ dysfunction; Any reason that, in the opinion of the investigator, contraindicates that the patient participates in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junnian Zheng, MD
Phone
86-0516-83372010
Email
jnzheng@xzmc.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huizhong Li, MM
Phone
86-0516-85582635
Email
lhz@xzmc.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junnian Zheng, MD
Organizational Affiliation
Xuzhou Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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DC1s-CTL Cellular Therapy for Renal Cell Carcinoma
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