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

Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Breast Cancer

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.

Study Overview

• Status: Withdrawn
• Conditions: Advanced Breast Cancer
• Intervention / Treatment: Procedure: cryotherapy; Biological: Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Breast Cancer

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510665
      • Institutional Review Board of Guangzhou Fuda Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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	Procedure: cryotherapy; the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.; 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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	ORR.The proportion of patients who had a best response rating of complete response and partial response.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	PFS.The time of patients from randomization to death caused by the progression of the tumor or any cause.	3 years
Time tumor progression	TTP.The time of patient from randomization to objective progress of the tumor.	1 year
Disease control rate	DCR.The proportion of patients who had a best response rating of complete response, partial response,or stable disease.	1 year
Overall survival	OS.The time of patient from randomization to death caused by any cause	3 years
Symptom remission rate	SRR. The proportion of symptoms are alleviated in all evaluative cases.	1 year

Collaborators and Investigators

• Sponsor: Fuda Cancer Hospital, Guangzhou
• Collaborators: Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
• Investigators: Study Chair: Jibing Chen, Doctor, Guangzhou Fuda Cancer Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2019
• Primary Completion (ACTUAL): April 5, 2020
• Study Completion (ACTUAL): July 5, 2020

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: May 2, 2018
• First Posted (ACTUAL): May 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: breast cancer; bispecific antibody; MUC1; activated CIK
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Antibodies, Bispecific
• Other Study ID Numbers: CD3-MUC1 in breast cancer

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No