Immunotherapy Using Precision T Cells Specific to Personalized Neo-antigen for the Treatment of Advanced Malignant Tumor of Biliary Tract

NCT02632019 | Unknown Phase 1

• 1 other identifier: EHBHKY2015-02-006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: The purpose of this study is to evaluate the safety and prognosis of dendritic cell-precision T cell for neo-antigen in the treatment of advanced biliary tract malignant tumor. Methods: This study designs a novel therapy using dendritic cell-precision multiple antigen T cells. 40 patients will be enrolled. They are randomly divided into gemcitabine group and dendritic cell-precision T cell for neo-antigen combined with gemcitabine group. Gemcitabine treatments will be performed once a week with a total of six times. Dendritic cell-precision T cell for neo-antigen combined with gemcitabine treatment: Gemcitabine: once a week with a total of six times before 60 days prior to the start of drawing blood. Dendritic cell-precision T cell for neo-antigen: once per 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.

Conditions

Advanced Biliary Tract Malignant Tumor

Keywords

advanced biliary tract malignant tumor; dendritic cell; precision T cell for neo-antigen

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)

gemcitabine

ACTIVE COMPARATOR

Gemcitabine treatments will be performed once a week with a total of six times

Drug: Gemcitabine

Dendritic cell-precision T cell for neo-antigen

EXPERIMENTAL

Dendritic cell-precision T cell for neo-antigen (DC-PNAT) combined with gemcitabine treatment: Gemcitabine: once a week with a total of six times before 60 days prior to the start of drawing blood. DC-PNAT: once per 3 weeks with a total of three periods.

Drug: Gemcitabine; Biological: Dendritic cell-precision T cell for neo-antigen combined with gemcitabine treatment

Interventions

Gemcitabine DRUG

Gemcitabine 1000mg/m2, Physiological saline 100ml:IV (in the vein) once a week with a total of six times.

Dendritic cell-precision T cell for neo-antigen; gemcitabine

Dendritic cell-precision T cell for neo-antigen combined with gemcitabine treatment BIOLOGICAL

Gemcitabine: Gemcitabine 1000mg/m2, Physiological saline 100ml: IV (in the vein) once a week with a total of six times before 60 days prior to the start of drawing blood. DC-PNAT: DC cell suspension (1×107 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. PNAT cell suspension (1-6×109 PNAT + 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.

Dendritic cell-precision T cell for neo-antigen

Eligibility Criteria

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

You may qualify if:

• \. Age 18\~65 years old, male or female;2. Life expectancy \> 6 months;3. Eastern Cooperative Oncology Group (ECOG) score: 0-2;4. Laboratory examination: ① white blood cell ≥ 3 x 109/L. blood platelet count ≥ 60 x 109/L; hemoglobin ≥85g/L; ② total bilirubin ≤100 mol/L; aminopherase less than five times of the normal; ③ serum creatinine less than 1.5 times of the normal;5. Signed informed consent;6. Patients with fertility are willing to use contraceptive method.

You may not qualify if:

• \. Expected Overall survival \< 6 months;2.Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, Etc.3.serum creatinine \> 2.5mg/dL; Serum Glutamic Oxaloacetic Transaminase (SGOT) \> 5 times of the normal;total bilirubin \> 100μmol/L; 4.Other drugs, biological, chemotherapy or radiation therapy were used within 1 months;5. Without signed Informed consent.

Sponsors & Collaborators

• Second Military Medical University: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, 200438, China

RECRUITING

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MeSH Terms

Interventions

Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Xiaoqing Jiang, MD

  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 12, 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)