DC1s-CTL Cellular Therapy for Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

Official title:

DC1s-CTL Cell Therapy to Treat Patients With Renal Cell Carcinoma After Radical Resection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02787915
• Other study ID #: XYFY2016-KL012-01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: May 26, 2016
• Last updated: May 31, 2016
• Start date: September 2016
• Est. completion date: August 2019

Study information

• Verified date: May 2016
• Source: Xuzhou Medical College
• Contact: Junnian Zheng, MD
• Phone: 86-0516-83372010
• Email: jnzheng[@]xzmc.edu.cn
• Is FDA regulated: No
• Health authority: China: Jiangsu Provincial Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Biological:
• DC1-CTL
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 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	T cell subsets figures		12 weeks	No
Other	Serum cytokine secretion figures		12 weeks	No
Primary	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.	24 weeks	Yes
Secondary	G250 mRNA figures		24 weeks	No