What is the mechanism of action of this treatment?

Common treatments for breast cancer include hormone therapy, chemotherapy, targeted therapy, and immunotherapy. Hormone therapies, such as tamoxifen, block hormone receptors to slow the growth of hormone receptor-positive cancers. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells. Targeted therapies, like trastuzumab, inhibit specific proteins involved in cancer cell growth. Immunotherapies, including CAR-T cell therapies like huMNC2-CAR44 or huMNC2-CAR22, engineer T cells to target and destroy cancer cells expressing specific antigens, such as the cleaved form of MUC1 (MUC1*). These treatments are crucial as they offer personalized approaches to effectively target and eliminate cancer cells, potentially leading to better outcomes and fewer side effects for breast cancer patients.

What side effects are associated with this type of intervention?

Common side effects of CAR-T cell therapies, including those targeting MUC1* like huMNC2-CAR44 or huMNC2-CAR22, often include cytokine release syndrome (CRS), which can range from mild to severe and may cause fever, fatigue, and low blood pressure. Neurological toxicities are also common, potentially leading to confusion, headaches, or seizures. Other side effects may include infections due to immunosuppression, cytopenias (low blood cell counts), and organ toxicities. These side effects necessitate close monitoring and supportive care during and after treatment.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for breast cancer. Trastuzumab (Herceptin) is a monoclonal antibody targeting HER2-positive breast cancer, often used in combination with chemotherapy. Pertuzumab (Perjeta) is another HER2-targeted therapy used alongside trastuzumab and docetaxel. Ado-trastuzumab emtansine (Kadcyla) is an antibody-drug conjugate combining trastuzumab with a cytotoxic agent. For hormone receptor-positive breast cancer, CDK 4/6 inhibitors like palbociclib (Ibrance) and ribociclib (Kisqali) are used in combination with endocrine therapy. Pembrolizumab (Keytruda), an immune checkpoint inhibitor, has also been approved for certain cases of triple-negative breast cancer. These treatments represent significant advancements in targeting specific cancer pathways and enhancing the immune response against breast cancer cells.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: 1) Immune checkpoint inhibitors such as pembrolizumab and atezolizumab, which have shown efficacy in various cancers including breast cancer. 2) Antibody-drug conjugates like trastuzumab deruxtecan, which target HER2-positive breast cancer cells. 3) PARP inhibitors such as olaparib and talazoparib, particularly for patients with BRCA mutations. 4) Novel combinations of immunotherapy with targeted therapies, such as combining PD-1/PD-L1 inhibitors with HER2-targeted agents or PARP inhibitors.

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CAR T-cell Therapy

CAR T-Cell Therapy for Breast Cancer

Phase 1

Recruiting

Led By Yuan Yuan, MD PhD

Research Sponsored by Minerva Biotechnologies Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be capable of understanding and providing a written informed consent.

Patients with HER2 positive breast cancer must have received at least 3 prior HER2-directed therapies (trastuzumab, pertuzumab, TDM-1 or others) in the metastatic setting.

Must not have

Known second malignancy that is progressing or requires active treatment.

Hemoglobin <9 mg/dl (transfusion permitted to achieve this).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a patient's own immune cells, which are modified in a lab to better recognize and attack cancer cells. The treatment targets patients with advanced breast cancer that expresses a specific protein called MUC1*. The modified T cells are designed to find and destroy these cancer cells by recognizing the MUC1* marker. MUC1 is a cancer-associated antigen that is overexpressed and modified by tumor cells in over half of all cancer cases, and it has been pursued as a target for immunotherapy.

Who is the study for?

This trial is for adults with advanced breast cancer that tests positive for a specific protein, MUC1*. Participants must have tried standard treatments and be in good enough health to give consent. Women of childbearing age need a negative pregnancy test and all fertile participants must agree to use contraception. People can't join if they're on high-dose steroids, have certain blood counts or organ dysfunction, untreated brain metastases, active infections, other cancers needing treatment, severe heart issues or are HIV positive.

What is being tested?

The study is testing two types of CAR T cell therapies (huMNC2-CAR44 or huMNC2-CAR22) designed to target the MUC1* protein on breast cancer cells. It's an early-phase trial to see how safe these therapies are and how well they work against this form of breast cancer.

What are the potential side effects?

CAR T cell therapy can cause immune system reactions like fever and fatigue; it may also affect normal blood cells leading to increased infection risk. Organ inflammation is possible too. Each person might experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and sign a consent form.

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I have had at least 3 treatments for HER2 positive breast cancer.

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My breast cancer diagnosis and hormone receptor status are confirmed by a pathology review.

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My cancer can be measured by scans.

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I am able to care for myself but may need occasional help.

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I have triple negative breast cancer and have undergone at least 2 chemotherapy treatments for it in its advanced stage.

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I have had 3 hormone treatments and 2 chemotherapy treatments for my cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have another cancer that is getting worse or needs treatment.

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My hemoglobin level is below 9 mg/dl, but I can receive a transfusion.

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I do not have any ongoing infections that aren’t responding to treatment.

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I am HIV positive.

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I cannot take cyclophosphamide due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events

Secondary study objectives

Antitumor Activity

In vivo persistence

Preliminary Antitumor Activity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Triple NegativeExperimental Treatment1 Intervention

Dose Expansion - 15 patients will be enrolled with triple negative metastatic breast cancer.

Group II: LuminalExperimental Treatment1 Intervention

Dose Expansion - 15 patients will be enrolled with luminal (hormone receptor positive, HER2 negative) metastatic breast cancer.

Group III: HER2+Experimental Treatment1 Intervention

Dose Expansion - 15 patients will be enrolled with HER2+ metastatic breast cancer.

Group IV: Dose EscalationExperimental Treatment1 Intervention

Dose escalation or de-escalation is tested in cohorts of 3 patients each using standard "3+3" dose-finding.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include hormone therapy, chemotherapy, targeted therapy, and immunotherapy. Hormone therapies, such as tamoxifen, block hormone receptors to slow the growth of hormone receptor-positive cancers. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells. Targeted therapies, like trastuzumab, inhibit specific proteins involved in cancer cell growth. Immunotherapies, including CAR-T cell therapies like huMNC2-CAR44 or huMNC2-CAR22, engineer T cells to target and destroy cancer cells expressing specific antigens, such as the cleaved form of MUC1 (MUC1*). These treatments are crucial as they offer personalized approaches to effectively target and eliminate cancer cells, potentially leading to better outcomes and fewer side effects for breast cancer patients.

A novel and efficient CD22 CAR-T therapy induced a robust antitumor effect in relapsed/refractory leukemia patients when combined with CD19 CAR-T treatment as a sequential therapy.CAR T cells targeting options in the fight against multiple myeloma.An antibody that locks HER3 in the inactive conformation inhibits tumor growth driven by HER2 or neuregulin.