NCT02886897

Brief Summary

Background: Combinations of dendritic and cytokine-induced killer cell (D-CIK) based adoptive immunotherapy and anti-PD-1 antibody may enhance the immune response and stop cancer cells from growing. Objective: Phase II clinical trial to investigate the safety, clinical activity and toxicity of combinations of D-CIK and anti-PD-1 antibody in patients with treatment-refractory solid tumors. Methodology: Phase II clinical trial in patients with advanced metastatic hepatocellular carcinoma, renal cell carcinoma,bladder cancer,colorectal cancer,non-small-cell lung cancer,breast cancer and other solid cancers. The D-CIK was isolated from peripheral blood of participants,then activated,expanded and incubated with anti-PD-1 antibody before infusion. The enough number (1.0-1.5 \*10\^10 cells) of D-CIK were infused back into participants.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

3.2 years

First QC Date

August 14, 2016

Last Update Submit

August 26, 2016

Conditions

Hepatocellular CarcinomaRenal Cell CarcinomaBladder CancerColorectal CancerNon-small-cell Lung CancerBreast Cancer

Keywords

Refractory solid tumorsDendritic and Cytokine-induced killer cellAnti-PD-1 antibodyCombination immunotherapy

Outcome Measures

Primary Outcomes (1)

  • Progress-free survival(PFS)

    PFS is defined as the time from the combined therapy until objective tumor progression or death.

    12 Months

Secondary Outcomes (4)

  • Overall survival (OS)

    12 Months

  • Laboratory findings

    6 Months

  • Objective response rate

    12 Months

  • Severity of adverse events

    12 Months

Study Arms (1)

D-CIK and anti-PD-1 Immunotherapy

EXPERIMENTAL

D-CIK was incubated with anti-PD-1 antibody before infused back into participants

Biological: D-CIK and anti-PD-1 antibody

Interventions

D-CIK and anti-PD-1 antibodyBIOLOGICAL

Autologous dendritic and cytokine-induced killer cells (D-CIK)(1.0-1.5\*10\^10 cells)were incubated with anti-PD-1 antibody and infused into participants.

D-CIK and anti-PD-1 Immunotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participantswith treatment-refractory advanced hepatocellular carcinoma, renal cell carcinoma,bladder cancer,colorectal cancer,non-small-cell lung cancer,breast cancer and other solid cancers.
  • Age 18 to 75 years.
  • Willing to sign a durable power of attorney.
  • Able to understand and sign the Informed Consent Document.
  • Life expectancy of greater than three months.
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the preparative regimen.
  • Adequate organ function.
  • Serology:
  • Seronegative for HIV antibody.
  • Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
  • Hematology:
  • WBC (\> 3000/mm(3)).
  • Platelet count greater than 100,000/mm(3).
  • Hemoglobin greater than 8.0 g/dl.
  • +4 more criteria

You may not qualify if:

  • Previous treatment with anti-CTLA-4 and anti-PD-1/PD-L1.
  • Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
  • Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
  • History of autoimmune disease
  • Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
  • Concurrent antineoplastic therapies and systemic steroid therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen University, Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (5)

  • Taube JM, Anders RA, Young GD, Xu H, Sharma R, McMiller TL, Chen S, Klein AP, Pardoll DM, Topalian SL, Chen L. Colocalization of inflammatory response with B7-h1 expression in human melanocytic lesions supports an adaptive resistance mechanism of immune escape. Sci Transl Med. 2012 Mar 28;4(127):127ra37. doi: 10.1126/scitranslmed.3003689.

    PMID: 22461641RESULT

  • Lee JH, Lee JH, Lim YS, Yeon JE, Song TJ, Yu SJ, Gwak GY, Kim KM, Kim YJ, Lee JW, Yoon JH. Adjuvant immunotherapy with autologous cytokine-induced killer cells for hepatocellular carcinoma. Gastroenterology. 2015 Jun;148(7):1383-91.e6. doi: 10.1053/j.gastro.2015.02.055. Epub 2015 Mar 4.

    PMID: 25747273RESULT

  • Mahoney KM, Rennert PD, Freeman GJ. Combination cancer immunotherapy and new immunomodulatory targets. Nat Rev Drug Discov. 2015 Aug;14(8):561-84. doi: 10.1038/nrd4591.

    PMID: 26228759RESULT

  • Pan K, Guan XX, Li YQ, Zhao JJ, Li JJ, Qiu HJ, Weng DS, Wang QJ, Liu Q, Huang LX, He J, Chen SP, Ke ML, Zeng YX, Xia JC. Clinical activity of adjuvant cytokine-induced killer cell immunotherapy in patients with post-mastectomy triple-negative breast cancer. Clin Cancer Res. 2014 Jun 1;20(11):3003-11. doi: 10.1158/1078-0432.CCR-14-0082. Epub 2014 Mar 25.

    PMID: 24668644RESULT

  • Dai C, Lin F, Geng R, Ge X, Tang W, Chang J, Wu Z, Liu X, Lin Y, Zhang Z, Li J. Implication of combined PD-L1/PD-1 blockade with cytokine-induced killer cells as a synergistic immunotherapy for gastrointestinal cancer. Oncotarget. 2016 Mar 1;7(9):10332-44. doi: 10.18632/oncotarget.7243.

    PMID: 26871284RESULT

MeSH Terms

Conditions

Carcinoma, HepatocellularCarcinoma, Renal CellUrinary Bladder NeoplasmsColorectal NeoplasmsCarcinoma, Non-Small-Cell LungBreast Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesUrinary Bladder DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Yi-Xin Zeng, Ph.D.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Chuan Xia, Ph.D.

CONTACT

862087345699xiajch@sysucc.org.cn

Yi-Xin Zeng, Ph.D.

CONTACT

862087343333zengYX@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Biotherapy;Principal Investigator;Professor

Study Record Dates

First Submitted

August 14, 2016

First Posted

September 1, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

September 1, 2016

Record last verified: 2016-08

Locations

CN(1)