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

Fuda Cancer Hospital, Guangzhou

Status and phase: Withdrawn; Phase 2

Conditions: Advanced Breast Cancer

Treatments: Procedure: cryotherapy; Biological: Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Breast Cancer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03524261

CD3-MUC1 in breast cancer

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups

Cryotherapy

Experimental group

Description:

the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.

Treatment:

Procedure: cryotherapy

Cryotherapy & Activated CIK and bispecific antibody

Active Comparator group

Description:

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

Treatment:

Biological: Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Breast Cancer

Procedure: cryotherapy

Conventional therapy

No Intervention group

Description:

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).