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CAR T-cell Therapy

CAR T-cell Therapy for Breast Cancer

Phase 1
Led By Joanne Mortimer, MD
Research Sponsored by Minerva Biotechnologies Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmation of diagnosis of breast cancer by pathology review of initial or subsequent biopsy or other pathologic material at the City of Hope Pathology department. ER, PR, and HER2 status known and documented per ASCO/CAP guidelines.
Patients with triple negative disease must have received at least 2 prior lines of chemotherapy in the metastatic setting.
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upup to 15 years
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Metastatic Breast Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
If you have hormone receptor positive disease, you must have already tried at least 3 different hormone therapies and 2 different chemotherapy treatments for your advanced cancer.


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

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.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterOTHER
550 Previous Clinical Trials
2,252,497 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
Minerva Biotechnologies CorporationLead Sponsor
Joanne Mortimer, MDPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
684 Total Patients Enrolled
2 Trials studying Breast Cancer
621 Patients Enrolled for Breast Cancer

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: Luminal, Triple Negative, HER2+, Dose Escalation
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

Has the FDA approved huMNC2-CAR44 CAR T cells for therapeutic use?

"Given its status as a Phase 1 study, with limited data on efficacy and safety, the team at Power rates huMNC2-CAR44 CAR T cells' safety level at 1."

Answered by AI
~14 spots leftby Jan 2025