Immunotherapy Using Pluripotent Killer-Programmed Cell Death 1 (PIK-PD-1) Cells for the Treatment of Advanced Hepatocellular Carcinoma

NCT02632006 | Unknown Phase 1

• 1 other identifier: EHBHKY2015-02-009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: The purpose of this study is to evaluate the safety and efficacy of PIK-PD-1 Cells in the treatment of advanced Hepatocellular Carcinoma. Methods: This study designs a novel therapy using PIK-PD-1 cells. 40 patients with advanced Hepatocellular Carcinoma will be enrolled. They are randomly divided into dendritic cell-precision multiple antigen T cells (DC-PMAT) group and PIK-PD-1 cells group. Both DC-PMAT treatment and PIK-PD-1 cells treatment will be performed every 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.

Conditions

Advanced Hepatocellular Carcinoma

Keywords

PIK-PD-1 Cells; dendritic cell-precision multiple antigen T cells; advanced hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  2 yeas

Secondary Outcomes (2)

• Progress-free survival

  2 yeas

• Quality of life

  2 yeas

Study Arms (2)

PIK-PD-1 cells

EXPERIMENTAL

PIK-PD-1 cells treatment will be performed every 3 weeks with a total of three periods.

Biological: PIK-PD-1 cells

DC-PMAT

ACTIVE COMPARATOR

DC-PMAT cells treatment will be performed every 3 weeks with a total of three periods.

Biological: DC-PMAT

Interventions

PIK-PD-1 cells BIOLOGICAL

DC cell suspension (1×10\*7 DC+ physiological saline \+ 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PIK-PD-1 cell suspension (1-6×10\*9 PIK-PD-1 + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.

PIK-PD-1 cells

DC-PMAT BIOLOGICAL

DC cell suspension (1×10\*7 DC+ physiological saline \+ 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PMAT cell suspension (1-6×10\*9 PMAT + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.

DC-PMAT

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 20\~70 years old, male or female; 2. Barcelona Clinic Liver Cancer(BCLC) C stage; no indication for operation, local treatment (Transcatheter Arterial Chemoembolization (TACE), percutaneous icro wave coagulation therapy (PMCT), percutaneous ethanol injection therapy (PEIT)) and radiation therapy; unable or unwilling to receive sorafenib therapy; 3.Child-Pugh score ≤ 9; 4.Eastern Cooperative Oncology Group (ECOG) score ≤ 2; 5.Life expectancy\>3 months; 6. white blood cell (WBC) \> 3 x 10\*9/L, Neutrophils \> 1 x 10\*9/L, lymphocyte \> 1 x 10\*9/L, hemoglobin ≥8.5g/dl, Platelet ≥50×109/L, prothrombin time (PT) no more than 3 seconds, Cr and blood urea nitrogen (BUN) less than 3 times of the normal level; 7. Adequate venous access, blood cell production without other taboos; 8. Signed informed consent.

You may not qualify if:

• \. Immunosuppressive therapy needed with autoimmune disease or organ transplantation history； 2. HIV/Syphilis infection; 3. Positive blood culture or imaging evidence infection; 4. Other drugs, gene therapy, biological, chemotherapy or radiation therapy were used within 1 months.
• \. The history of allergic reactions in cell therapy or cytokine. 6. PD-1 antibodies have been used before, or allergies due to PD-1 antibody drugs.
• \. History of interstitial lung disease. 8. History of esophagus varicosis rupture haemorrhage. 9. Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, Etc.

Sponsors & Collaborators

• Second Military Medical University: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, 200438, China

RECRUITING

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Study Officials

• Qijun Qian, PHD

  Eastern Hepatobiliary Surgery Hospital

  STUDY CHAIR

Central Study Contacts

Qijun Qian, PHD

CONTACT

+86-21-65580677; qianqj@sino-gene.cn

Huajun Jin, PHD

CONTACT

+86-21-81875372; hj-jin@Hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2015
• First Posted: December 16, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 1, 2016

Record last verified: 2015-09

Locations

CN (1)