ClinicalTrials.gov record NCT04430595

Multi-4SCAR-T Therapy Targeting Breast Cancer

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 5, 2026

Multiple 4SCAR-T Cell Therapy Targeting Breast Cancer

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age18 years old to 75 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1/2 study evaluates infusions of multiple fourth-generation CAR‑T cells that target Her2, GD2, and CD44v6 in people with stage III, IV, or relapsed breast cancer. The trial aims to assess feasibility, safety, anti-tumor activity, and how long the CAR‑T cells persist. Participants receive the CAR‑T infusion and are followed with imaging and blood tests (qPCR on Days 7, 14, 21, 28, 60, and 90) and adverse-event assessments for up to three years.

What it is studying. The study is testing whether giving multiple 4th‑generation CAR‑T cells that target Her2, GD2, and CD44v6 is feasible and safe in breast cancer, and whether those cells show anti-tumor activity and persist in patients’ blood.

What the researchers hope to learn. Scientific goals: determine feasibility, safety, and anti-tumor activity of multi-target 4SCAR‑T therapy; define the toxicity profile (CTCAE v4.0); measure CAR‑T cell expansion and persistence by qPCR; and evaluate progression-free and overall survival.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Biological
  • 4SCAR T cells

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.
  • 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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants give written informed consent and receive an infusion of 4SCAR T cells (4SCAR‑GD2, 4SCAR‑Her2, and 4SCAR‑CD44v6). They will have imaging scans to check disease status and repeated blood draws to measure CAR‑T cell expansion and persistence by qPCR on Days 7, 14, 21, 28, 60, and 90 after infusion. The study team will monitor and record adverse events and will track survival outcomes, including progression‑free and overall survival, for up to three years.

How the study is structured. Open-label, single-group Phase 1/2 interventional trial. All participants receive an infusion of 4SCAR-GD2, -Her2, and -CD44v6 CAR‑T cells. The study will record adverse events (using Common Toxicity Criteria for Adverse Effects v4.0) over three years, assess tumor response by imaging, measure CAR‑T expansion and persistence in blood by qPCR at specified days after infusion (Days 7, 14, 21, 28, 60, and 90), and evaluate survival outcomes including progression-free and overall survival.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Breast Cancer. Does it apply to my diagnosis?
  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Gaucher disease

Clinical trials64 trials listed for Gaucher diseaseEvery trial the registry lists for Gaucher disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Gaucher disease researchLatest monthly update: September 2026. Includes: Platelet release. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jun 1, 2027 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Study completion
Dec 31, 2030 (estimated)
Target enrollment
100 participants (estimated)
Last updated on registry
Aug 26, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Shenzhen Geno-Immune Medical Institute

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

CAR-T cells
A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
relapsed
A condition that improved with treatment and has since returned or worsened.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
immunosuppressive
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
ECOG
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
ANC
The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
ULN
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
corticosteroid
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
investigational drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
during screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
sponsor
The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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