huMNC2-CAR44 CAR T cells for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope Medical Center, Duarte, CA
Breast Cancer+1 More
huMNC2-CAR44 CAR T cells - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new type of immunotherapy may help treat breast cancer.

See full description

Eligible Conditions

  • Breast Cancer
  • Metastatic Breast Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether huMNC2-CAR44 CAR T cells will improve 1 primary outcome and 3 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Up to 365 days after the T cell infusion.

Up to 15 years
Antitumor Activity
Preliminary Antitumor Activity
Day 365
In vivo persistence
Day 35
Incidence of Adverse Events

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

Luminal
1 of 4
Dose Escalation
1 of 4
Triple Negative
1 of 4
HER2+
1 of 4
Experimental Treatment

This trial requires 69 total participants across 4 different treatment groups

This trial involves 4 different treatments. HuMNC2-CAR44 CAR T Cells is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Luminal
Biological
Dose Expansion - 15 patients will be enrolled with luminal (hormone receptor positive, HER2 negative) metastatic breast cancer.
Dose Escalation
Biological
Dose escalation or de-escalation is tested in cohorts of 3 patients each using standard "3+3" dose-finding.
Triple Negative
Biological
Dose Expansion - 15 patients will be enrolled with triple negative metastatic breast cancer.
HER2+
Biological
Dose Expansion - 15 patients will be enrolled with HER2+ metastatic breast cancer.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 15 years for reporting.

Closest Location

City of Hope Medical Center - Duarte, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Confirmation of diagnosis of breast cancer by internal pathology review of initial or subsequent biopsy or other pathologic material at FHCRC/SCCA. ER, PR, and HER2 status known and documented per ASCO/CAP guidelines.
Patients must have received standard metastatic systemic therapy per NCCN guidelines or institutional practice which are known to confer benefit. No maximum on number of prior systemic treatment regimens.
Patients with hormone receptor positive disease must have received at least 3 prior endocrine therapies and at least 2 prior lines of chemotherapy in the metastatic setting.
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.
Patients with triple negative disease must have received at least 2 prior lines of chemotherapy in the metastatic setting.
MUC1* membrane expression ≥30% by immunohistochemistry on a tumor specimen obtained at screening or previous tumor specimen.
Patients must be 18 years of age or older, of any gender, race or ethnicity.
Patients must be capable of understanding and providing a written informed consent.
Patients must have a Karnofsky performance status of ≥ 60%.
Extra skeletal disease that can be accurately measured by CT or MRI per RECIST 1.1

Patient Q&A Section

Can breast cancer be cured?

"It is clear that mammography, screening, and proper treatment can help people with early stage [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). However, there are still many people who will be diagnosed and must endure much more pain and suffering. The idea of cure is a false one. I hope that this book will lead to a little bit of awareness to cancer patients, doctors, nurses, and other medical professionals who look into the idea of cure. To cure means to eliminate all types of cancer and can only be achieved in theory, but not in reality." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"The signs can be grouped into different categories: palpable, mammograph, and clinical. The main manifestations of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in the clinical category are: cancer-associated symptoms, palpable masses, and atypia, while in the mammograph category we can see atypical mammographic appearances. All these signs should be confirmed under ultrasound and/or magnetic resonance imaging." - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"The causes of the development of breast cancer are largely unknown and some research reveals that the causes of breast cancer are complicated. In addition, some research shows breast cancer that is estrogen receptor-positive and HER 2, which are markers of good prognosis, are more common. These markers can be used to determine whether a patient needs more aggressive chemotherapy treatments. Additionally, when assessing whether mammography screening is a necessity for women the age of women can have an impact. Research shows that only women who are over the age of 50 require screening. However, research from 2013 shows it may be less effective at screening for certain genetic factors in low-risk women." - Anonymous Online Contributor

Unverified Answer

How many people get breast cancer a year in the United States?

"Approximately 250,000 new cases of breast cancer will be diagnosed in the United States in 2017. Breast cancer is the fourth leading cause of death among women in the United States.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"Treatment for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) may be dependent on many factors including the stage at diagnosis, the person's age, the location of the cancer, and the person's medical condition. Common treatments may include surgery, chemotherapy, radiation therapy, hormonal therapy, targeted therapy, or a combination of these." - Anonymous Online Contributor

Unverified Answer

What is breast cancer?

"Breast cancer is a debilitating disease that destroys tissues, which can result in lumpectomies and mastectomies that adversely affect a cancer patients' future quality of life. The overall lifetime risk of developing breast cancer is 1 in 12 in the UK. The lifetime risk of developing breast cancer is about 60% in the US. Half of women who develop breast cancer will die within 5 years after diagnosis. Breast cancer can occur at many different stages of a woman's life. Screening, mammography and ultrasound are recommended by national and international organisations for pre-menopausal patients. Screening is recommended for post-menopausal patients at ages 75 and 80, with further screening every three years following the age of 70." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for breast cancer?

"The key to successful clinical trial recruitment is early identification of the appropriate trial population using an appropriately tailored eligibility recruitment strategy and an individualized consent document." - Anonymous Online Contributor

Unverified Answer

Is humnc2-car44 car t cells safe for people?

"Results from a recent clinical trial, we have found that hNC-CTLA4-CAR(CD19z) chimeric T cells can be safely administered to patients with relapsed or refractory B-cell malignancies. The T cells expanded rapidly in most patients, and a small number had responses to residual tumor. Results from a recent clinical trial indicated that hNC-CTLA4-CAR(CD19z) T cells are safe and can be safely administered for patients in relapse or refractory settings, in combination with standard therapies." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in humnc2-car44 car t cells for therapeutic use?

"The use of HCT-C cells is being considered and used for adoptive cell transfer with or without donor cell expansion in conjunction with a stem cell transplantation. The use of HCT-C cells seems to be of great value in generating a patient-specific T-cell repertoire for adoptive cell therapy." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating breast cancer?

"Even with all the advances in the treatment options available, we still lack one of the key elements of a new breast cancer treatment, i.e., a drug that works without requiring surgery.
Other new discoveries and new approaches for the treatment of breast cancer will undoubtedly have an important role to play in future advances in breast cancer therapy. At the same time, we will keep on discovering new drugs. One of the interesting discoveries of the twentieth century was the introduction of the “selective estrogen receptor modulators,” which have had an important role to play in the management of breast cancer." - Anonymous Online Contributor

Unverified Answer

How does humnc2-car44 car t cells work?

"humnc2-car44 car t cell adoptive adoptive transfer effectively suppresses breast cancer in an NAC-sensitive mouse model. This finding may serve as the foundation of clinical development" - Anonymous Online Contributor

Unverified Answer

What is the latest research for breast cancer?

"In this review we summarized an array of breast cancer research, from cell biology to the clinical endpoints, for example in breast cancer survivors. For each study we used the reporting type and level to define its characteristics. Thus, these results will be useful for those who want to evaluate other research reports. We are confident that such a database is sorely requested by those interested in current treatment strategies for breast cancer that might impact the course of treatment for this disease in a clinical setting." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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