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CAR T-cell Therapy

T-Cell Therapy for Breast Cancer

Phase 1
Waitlist Available
Led By Shanu Modi, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chemotherapy, targeted therapy (such as a tyrosine kinase inhibitor), or radiotherapy must have been completed at least 14 days before administration of T-cells. Prior immunotherapy with checkpoint blockade (i.e., PD1 inhibitor, PDL1 inhibitor, or CTL4-antagonist or similar agent) must have been completed more than 1 month before the T-cell infusion.
Breast cancer pathologically confirmed at MSKCC or outside institutions for screening phase
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing the safety of different doses of T cells that have been collected from the blood and modified to target HER2-negative breast cancer cells. The goal is to find a safe dose of these modified T cells that can be used to treat patients with metastatic breast cancer.

Who is the study for?
This trial is for adults with advanced HER2-negative breast cancer who've had at least one chemo treatment and whose disease has progressed. They must have finished any previous treatments, including immunotherapy, certain days before getting T-cells and agree to use contraception. People can't join if they're on daily steroids, have autoimmune diseases, are pregnant or breastfeeding, or have untreated brain metastases.Check my eligibility
What is being tested?
The study tests different doses of modified T cells targeting mesothelin in patients with metastatic breast cancer to find a safe level. Patients will receive Cyclophosphamide followed by the engineered T cells and AP1903 as part of the treatment process.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to the modified T cells attacking normal tissues, infusion-related symptoms like fever or chills, fatigue from Cyclophosphamide, and possible complications related to AP1903 administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I finished chemotherapy, targeted therapy, or radiotherapy at least 14 days ago and any immunotherapy over a month ago.
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My breast cancer diagnosis was confirmed through a biopsy.
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I am 18 or older with breast cancer that has spread.
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My latest cancer test shows I am HER2 negative.
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I have had chemotherapy for my cancer that has spread, and it has gotten worse.
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I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Maximum tolerated does (MTD)

Trial Design

1Treatment groups
Experimental Treatment
Group I: T-cell infusionExperimental Treatment3 Interventions
A single blood volume leukapheresis for harvesting of PBMCs will be performed, As the transduced T cells will be frozen, the timing of leukapheresis is not defined & can vary from patient to patient. Subsequently, a single dose of mesothelin-targeted T cells will be infused via intravenous catheter or central line (i.e., mediport). Patients will be monitored in the hospital and discharged home after a minimum of 48 hours. Patients will be monitored closely as outpatients for the next 2 months. Patients will be followed weekly as outpatients for the first 8 weeks after treatment. All patients will be hydrated intravenously, premedicated with acetaminophen & diphenhydramine, & administered cyclophosphamide at 1.5 g/m2 2 to 7 days (Day -7 to Day -2) before administration of mesothelin-targeted T cells.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
AP1903
2014
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,669 Total Patients Enrolled
202 Trials studying Breast Cancer
80,951 Patients Enrolled for Breast Cancer
United States Department of DefenseFED
863 Previous Clinical Trials
227,413 Total Patients Enrolled
36 Trials studying Breast Cancer
3,280 Patients Enrolled for Breast Cancer
Shanu Modi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
94 Total Patients Enrolled
2 Trials studying Breast Cancer
45 Patients Enrolled for Breast Cancer

Media Library

Mesothelin-targeted T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02792114 — Phase 1
Breast Cancer Research Study Groups: T-cell infusion
Breast Cancer Clinical Trial 2023: Mesothelin-targeted T cells Highlights & Side Effects. Trial Name: NCT02792114 — Phase 1
Mesothelin-targeted T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02792114 — Phase 1
Breast Cancer Patient Testimony for trial: Trial Name: NCT02792114 — Phase 1

Frequently Asked Questions

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

Is the recruitment of participants still ongoing for this research?

"This clinical trial is no longer accepting participants. The project was first made available to the public on June 1st 2016 and had its most recent update on March 21st 2022. There are currently 2600 trials looking for breast cancer patients, as well as 828 studies that actively recruiting individuals interested in AP1903 medication research."

Answered by AI

What prior research has utilized AP1903 in its investigations?

"The initial AP1903 study was conducted in 1997 at City of Hope Comprehensive Cancer Center; since then, 1092 trials have been completed. Currently, 828 active studies are recruiting participants with a considerable amount based out of Montvale, New jersey."

Answered by AI

How many sites within the state are currently undertaking this research?

"This clinical investigation is presently enrolling patients from 7 sites, such as Montvale and New york. To limit your travel commitments, it may be helpful to select the nearest clinic if you choose to join this trial."

Answered by AI

Has AP1903 achieved the recognition of regulatory approval from the FDA?

"Due to its Phase 1 status, our team at Power rated the safety of AP1903 as a 1 since there is limited data regarding efficacy and patient protection."

Answered by AI

What conditions can be alleviated by AP1903?

"AP1903 is a commonly prescribed medication for multiple sclerosis, yet its effects can also be observed in individuals suffering from acute myelocytic leukemia, mixed-cell type lymphoma, retinoblastoma and other maladies."

Answered by AI

How many volunteers are currently being accepted for this experiment?

"No longer recruiting, this trial was initially advertised on June 1st 2016 and most recently edited on March 21st 2022. For those exploring alternate studies, 2600 medical trials are currently attempting to recruit patients with breast cancer whereas 828 studies for AP1903 remain open for new enrolments."

Answered by AI

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

i have tried other drugs so far and they haven't worked.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
T-Cell Therapy for Advanced Breast Cancer
2016. "T-Cell Therapy for Advanced Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02792114.
All > Immunotherapy
~2 spots leftby Jun 2024
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