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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

Study Summary

This trial is testing a new way to treat breast cancer using a patient's own T cells that have been engineered to express a chimeric antigen receptor. This new treatment is specific for a cleaved form of MUC1.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events

Secondary outcome measures

Antitumor Activity

In vivo persistence

Preliminary Antitumor Activity

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Minerva Biotechnologies CorporationLead Sponsor

City of Hope Medical CenterOTHER

565 Previous Clinical Trials

1,921,391 Total Patients Enrolled

43 Trials studying Breast Cancer

6,649 Patients Enrolled for Breast Cancer

Yuan Yuan, MD PhDPrincipal InvestigatorCity of Hope Medical Center

Media Library

huMNC2-CAR44 CAR T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04020575 — Phase 1

Breast Cancer Research Study Groups: Triple Negative, Dose Escalation, Luminal, HER2+

Breast Cancer Clinical Trial 2023: huMNC2-CAR44 CAR T cells Highlights & Side Effects. Trial Name: NCT04020575 — Phase 1

huMNC2-CAR44 CAR T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04020575 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation currently open to new participants?

"This clinical trial is open for enrollment, as indicated on the website of clinicaltrials.gov. This study was first announced on January 15th 2020 and recently modified in December 22nd 2021."

Answered by AI

How many participants can the trial accommodate?

"Affirmative, according to the data on clinicaltrials.gov this study is still in need of participants. This medical trial was first posted on January 15th 2020 and last updated December 22nd 2021; 69 patients are being recruited from a single site."

Answered by AI