Breast CancerPhase 1/2NCT04430595
Multi-4SCAR-T Therapy Targeting Breast Cancer
A Phase 1/2 study testing 4SCAR T cells in people with Breast Cancer, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
Trial summary
The purpose of this study is to assess the feasibility, safety and efficacy of multiple 4th generation CAR-T cells targeting Her2, GD2, and CD44v6 surface antigen in breast cancer. Another goal of the study is to learn more about the activities of the multi-CAR T cells and their persistency in the patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 4SCAR T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2027to 31 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage III, IV or relapsed breast cancer confirmed by histology and biopsy.
- Age: ≥ 18 years and ≤ 75 years.
- 2 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.
- Side effects of chemotherapy have subsided.
- The target antigens GD2, CD44v6, or Her2 is expressed in malignancy tissues by immuno-histochemical or flow cytometry.
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
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- Expected survival ≥ 12 weeks.
- Initial hematopoietic reconstitution with neutrophils (ANC) ≥ 1×10^6/L; platelet (PLT) ≥ 1×10^8/L.
- Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with serum creatinine ≤ 2×ULN; serum bilirubin ≤ 3×ULN; AST/ALT ≤ 2.5×ULN.
- Oxygen saturation ≥ 90%.
- Written, informed consent obtained prior to any study-specific procedures.
Who cannot join
- Airway obstruction caused by tumor.
- History of epilepsy or other central nervous system diseases.
- Patients who require systemic corticosteroid or other immunosuppressive therapy.
- History of prolonged or serious heart disease during QT.
- Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
- Inadequate liver and renal function with serum creatinine > 1.5 mg/dl; serum (total) bilirubin > 2.0 mg/dl; AST \& ALT > 3 x ULN.
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- Pregnant or lactating females.
- Serious active infection during screening.
- Active HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) infection or uncontrolled infection.
- Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shenzhen Geno-immuno Medical Institute
Shenzhen, Guangdong, 518000
Lung-ji Chang, phD, +86 0755-86573763, c@mkgimi.com
About this study
Official title: Multiple 4SCAR-T Cell Therapy Targeting Breast Cancer
The purpose of this study is to assess the feasibility, safety and efficacy of multiple 4th generation CAR-T cells targeting Her2, GD2, and CD44v6 surface antigen in breast cancer. Another goal of the study is to learn more about the activities of the multi-CAR T cells and their persistency in the patients.
Read the detailed description
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
Breast cancer is one of the most frequent cancer types in women. The average risk of a woman in the United States developing breast cancer in her life is about 13%. That means that there is a 1 in 8 chance she will develop breast cancer. Human epidermal growth factor receptor-2 (HER2) is one of the more well-researched genes in breast cancer so far. It has been reported that HER2 gene is overexpressed in 20% to 30% of breast cancer patients. HER2 is an important target for tumor gene therapy. In 2003, scientists confirmed the existence of breast cancer stem cells. In 2012, ganglioside GD2 was confirmed as an emerging marker of breast cancer stem cells. Targeting therapies for GD2 may help improve the survival rate and cure rate of breast cancer patients. Invasion and metastasis of tumor cells is the main cause of cancer death. CD44v6 is an adhesion molecule on the cell surface, which not only promotes epithelial-mesenchymal transition, degradation and remodeling of extracellular matrix, but also participates in organ-specific metastasis of tumor cells. Studies have shown that overexpression of CD44v6 is an important factor for the invasion and metastasis of breast cancer, and is closely related to the tumor size of the breast cancer, tumor staging, and lymph node metastasis. Therefore, CD44v6 may be an important target for the treatment of breast cancer. Using Her2-, GD2- and CD44v6-specific CAR-T cells may effectively improve the immunotherapy treatment, prevent tumor cells from escaping treatment, and achieve the effect of long-term disease relief.
- Conditions
- Breast Cancer
- Being tested
- 4SCAR T cells
- Keywords
- CART, adoptive T cell transfer, Her2, GD2, CD44V6
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4SCAR T cellsBiological
Infusion of 4SCAR-GD2, -Her2 and -CD44v6 CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| Multiple 4SCAR T cells to treat breast cancer | Experimental | Multiple 4SCAR T cells to treat breast cancer Receives: Biological: 4SCAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events.
Determine the toxicity profile the multi-4SCAR-T cells with Common Toxicity Criteria for Adverse Effects version 4.0
Measured: 3 year
Secondary outcomes (3)
Anti-tumor effects
Disease status is defined by the image scan to get the outcomes such as Complete response/remission (CR), Very good partial response/remission (VGPR), etc.
Measured: 3 year
The expansion and persistence of CAR-T cells
The expansion and functional persistence of CART cells in the peripheral blood of patients will be measured by qPCR on Day 7, 14, 21, 28, 60 and 90 after infusion.
Measured: 3 months
Survival time of the patients
The survival time of the patients treated with the multi-4SCAR T cells, including progression free survival (PFS) and overall survival (OS) will be evaluated.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Jun 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Shenzhen Geno-Immune Medical InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Geno-Immune Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430595
- Sponsor's protocol ID
- GIMI-IRB-20005
- Status last verified
- Oct 2026
- First submitted
- 9 Jun 2020
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple 4SCAR-T Cell Therapy Targeting Breast Cancer
- ClinicalTrials.gov ID
- NCT04430595
- Acronym / sponsor ID
- GIMI-IRB-20005
- Conditions
- Breast Cancer
- Keywords
- CART, adoptive T cell transfer, Her2, GD2, CD44V6
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shenzhen Geno-Immune Medical InstituteUniversity, hospital or other
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the feasibility, safety and efficacy of multiple 4th generation CAR-T cells targeting Her2, GD2, and CD44v6 surface antigen in breast cancer. Another goal of the study is to learn more about the activities of the multi-CAR T cells and their persistency in the patients.
Detailed description
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
Breast cancer is one of the most frequent cancer types in women. The average risk of a woman in the United States developing breast cancer in her life is about 13%. That means that there is a 1 in 8 chance she will develop breast cancer. Human epidermal growth factor receptor-2 (HER2) is one of the more well-researched genes in breast cancer so far. It has been reported that HER2 gene is overexpressed in 20% to 30% of breast cancer patients. HER2 is an important target for tumor gene therapy. In 2003, scientists confirmed the existence of breast cancer stem cells. In 2012, ganglioside GD2 was confirmed as an emerging marker of breast cancer stem cells. Targeting therapies for GD2 may help improve the survival rate and cure rate of breast cancer patients. Invasion and metastasis of tumor cells is the main cause of cancer death. CD44v6 is an adhesion molecule on the cell surface, which not only promotes epithelial-mesenchymal transition, degradation and remodeling of extracellular matrix, but also participates in organ-specific metastasis of tumor cells. Studies have shown that overexpression of CD44v6 is an important factor for the invasion and metastasis of breast cancer, and is closely related to the tumor size of the breast cancer, tumor staging, and lymph node metastasis. Therefore, CD44v6 may be an important target for the treatment of breast cancer. Using Her2-, GD2- and CD44v6-specific CAR-T cells may effectively improve the immunotherapy treatment, prevent tumor cells from escaping treatment, and achieve the effect of long-term disease relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple 4SCAR T cells to treat breast cancer | Experimental | Biological: 4SCAR T cellsMultiple 4SCAR T cells to treat breast cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with stage III, IV or relapsed breast cancer confirmed by histology and biopsy.
- Age: ≥ 18 years and ≤ 75 years.
- 2 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.
- Side effects of chemotherapy have subsided.
- The target antigens GD2, CD44v6, or Her2 is expressed in malignancy tissues by immuno-histochemical or flow cytometry.
Key exclusion criteria (10 listed)
- Airway obstruction caused by tumor.
- History of epilepsy or other central nervous system diseases.
- Patients who require systemic corticosteroid or other immunosuppressive therapy.
- History of prolonged or serious heart disease during QT.
- Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4SCAR T cellsInfusion of 4SCAR-GD2, -Her2 and -CD44v6 CAR-T cells | Biological | Multiple 4SCAR T cells to treat breast cancer |
Primary outcome
Number of patients with adverse events.
Time frame: 3 year
Determine the toxicity profile the multi-4SCAR-T cells with Common Toxicity Criteria for Adverse Effects version 4.0
3 secondary outcomes
Anti-tumor effects
Time frame: 3 year
The expansion and persistence of CAR-T cells
Time frame: 3 months
Survival time of the patients
Time frame: 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 4SCAR T cells in people with Breast Cancer, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lung-Ji Chang, PhD (+86 0755-86573763, c@mkgimi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events. (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.