Clinical trial · Interventional
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
NCT03524261CI-TRIAL-00047730withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participants enrolled
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Breast Cancer | Biological | — | UNRESOLVED |
| cryotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cryotherapy
- description
- the maximum tumor length≥2 cm,cool down the lesion,result in degeneration, necrosis or loss of the lesion.
- interventionNames
- Procedure: cryotherapy
- type
- ACTIVE_COMPARATOR
- label
- Cryotherapy & Activated CIK and bispecific antibody
- 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
- interventionNames
- Biological: Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Breast Cancer
- Procedure: cryotherapy
- type
- NO_INTERVENTION
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.