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Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT03524261
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Study Description
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Brief Summary:
This is a phase II Randomized comparison clinical trial of activated CIK armed with anti-CD3-MUC1 bispecific antibody for advanced breast cancer. And the aim of this research is to study the clinical efficacy and safety of activated CIK armed with anti-CD3-MUC1 bispecific antibody for breast cancer.

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Biological: Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Breast Cancer Procedure: cryotherapy Phase 2

Detailed Description:

Primary breast carcinoma is one of the most common malignancies in China, ranking first in all malignant tumors of women.immunotherapy is considered to be one of the most promising means of human against cancer. This is a phase II clinical trial of single- center, The investigators plan to recruit for 90 patients with advanced breast cancer,and all patients are divided into three groups.one group will receive cryotherapy, one group will receive conventional therapy，and the rest one will receive mixed liquor of activated CIK and anti-CD3-MUC1 bispecific antibody together with cryotherapy.

The result of this study was statistic and analysed with the record of Response Evaluation Criteria In Solid Tumors(RECIST1.1) evaluation standard.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a phase II clinical trial of single-center, and it will divide into three groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: With the method of minimum randomized dynamic random by the interactive network response system (IWRS),Participants were assigned to three groups,receive cryotherapy,conventional therapy, and activated CIK armed with anti-CD3-MUC1 bispecific antibody together with cryotherapy .every participant has a unique identification number and emergency letter which have the information of group.
Primary Purpose: Treatment
Official Title: Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Breast Cancer
Estimated Study Start Date : April 5, 2020
Estimated Primary Completion Date : April 5, 2021
Estimated Study Completion Date : April 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cryotherapy
the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
 Procedure: cryotherapy
the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
Active Comparator: Cryotherapy & Activated CIK and bispecific antibody
the maximum tumor length≥2cm, use cryotherapy. the maximum tumor length<2 cm,Biological/Vaccine:Activated CIK and bispecific antibody CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
 Biological: Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Breast Cancer
CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1

Procedure: cryotherapy
the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
No Intervention: Conventional therapy
In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 1 year ]
    ORR.The proportion of patients who had a best response rating of complete response and partial response.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 3 years ]
    PFS.The time of patients from randomization to death caused by the progression of the tumor or any cause.

  2. Time tumor progression [ Time Frame: 1 year ]
    TTP.The time of patient from randomization to objective progress of the tumor.

  3. Disease control rate [ Time Frame: 1 year ]
    DCR.The proportion of patients who had a best response rating of complete response, partial response,or stable disease.

  4. Overall survival [ Time Frame: 3 years ]
    OS.The time of patient from randomization to death caused by any cause

  5. Symptom remission rate [ Time Frame: 1 year ]
    SRR. The proportion of symptoms are alleviated in all evaluative cases.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-75 years old
  • The patient is diagnosed as advanced breast cancer,MUC1 is positive
  • There is at least one tumor should be measured,and length≥10mm of focus not at lymph node or length≥10mm of focus at lymph node
  • The patient can't tolerate system(systemic chemotherapy/molecular targeted therapy) or local therapies
  • If the patient received adjuvant chemotherapy after local treatment,the time should be more than 4 weeks after the end of chemotherapy, and disease progression or metastasis patients can also assigned into the group
  • The time of surgical treatment≥ 3 months ;At the end of the intervention,radiotherapy and the end of the ablation time is more than 4 weeks
  • The expected survival time ≥12 weeks
  • The patient did not took any antitumor drugs within 4 weeks(any antitumor drugs, Chinese patent medicine including Delisheng injection,Kanglaite injection, Aidi injection
  • No serious disease are conflicts with the solution(such as autoimmune disease,immunodeficiency,organ transplantation)
  • Sign the informed consent

Exclusion Criteria:

  • medium or above ascites
  • Patient of second primary tumor or multiple primary cancer
  • Patients of T cell lymphoma、myeloma,and patients are using immunosuppressant
  • Systemic autoimmune diseases, allergic constitution or immunocompromised patients
  • Patients of chronic diseases need immune stimulant or hormone therapy
  • Patients of active bleeding or coagulant function abnormality（PT>16s、APTT>43s、TT>21s、INR≥2）,and patients of bleeding tendency or are receiving thrombolysis and anticoagulation and antiplatelet therapy
  • Women who is pregnant or during breast feeding or plan to pregnant in 2 years,and not willing to contraception during the test
  • Patients with brain、dura mater metastases or history of psychogenic
  • Gastrointestinal bleeding in the past six months or have clear gastrointestinal bleeding tendency,such as: patients of local active ulcerative lesions, defecate occult blood + + above shall not enter into group; defecate occult blood + depend on gastroscopy
  • Patients with severe stomach/esophageal varices and need for intervention treatment
  • Patients with abdominal fistula, gastrointestinal perforation or abdominal abscess within 4 weeks before the first treatment
  • Positive for HIV antibody
  • Patients who are allergic to computed tomography (CT) and magnetic resonance imaging (MRI) contrast agents at the same time, can't imaging assay
  • Patients accepted any experimental drugs or pilot medical apparatus and instruments in the past 4 weeks of first treatment
  • Other reasons the researchers think not suitable
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524261


Contacts
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Contact: Jibing Chen, Doctor +86-20-38993922 ext 8723 jibingchen398@163.com

Locations
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China, Guangdong
Institutional Review Board of Guangzhou Fuda Cancer Hospital Recruiting
Guangzhou, Guangdong, China, 510665
Contact: Jibing Chen, Doctor         
Sub-Investigator: Zhengcheng Li, Master         
Sub-Investigator: Peng Ma, Master         
Sub-Investigator: Chengsi He, Bachelor         
Sub-Investigator: Zhenzhen Wang, Bachelor         
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
Investigators
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Study Chair: Jibing Chen, Doctor Guangzhou Fuda Cancer Hospital
More Information
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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT03524261     History of Changes
Other Study ID Numbers: CD3-MUC1 in breast cancer
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fuda Cancer Hospital, Guangzhou:
activated CIK
MUC1
bispecific antibody
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Antibodies
Immunoglobulins
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs