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CAR T-cell Therapy

iC9-CAR.B7-H3 T cells for Breast Cancer

Phase 1

Waitlist Available

Led By Claire E Dees, MD, MSc

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing the safety of increasing doses of a type of immune cell therapy called CAR-T cells in patients with a specific type of breast cancer that has come back or not responded to treatment.

Who is the study for?

This trial is for individuals with triple-negative breast cancer (TNBC) that has returned or hasn't responded to treatment. Participants must meet certain health standards, but specific inclusion and exclusion criteria are not provided.Check my eligibility

What is being tested?

The study is testing the safety of increasing doses of a new therapy called iC9-CAR.B7-H3 T Cell Therapy in combination with two chemotherapy drugs, cyclophosphamide and fludarabine, in patients with TNBC.See study design

What are the potential side effects?

Potential side effects may include reactions related to CAR-T cell therapy such as fever, fatigue, headache, and immune system complications. Chemotherapy can cause nausea, hair loss, mouth sores, and increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

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

Toxicity: Cytokine Release Syndrome (CRS)

Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS)

Toxicity: NCI-CTCAE

Secondary outcome measures

Duration of Response (DOR)

Objective response rate

Overall Survival (OS)

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: iC9-CAR.B7-H3 T cellsExperimental Treatment3 Interventions

Specimen will be collected to prepare the iC9-CAR.B7-H3 T cells. Disease-fighting T cells will be isolated and modified to prepare the iC9-CAR.B7-H3 T cells. In part 2, the iC9-CAR.B7-H3 T cells are given by infusion after completion of lymphodepletion chemotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

fludarabine

2012

Completed Phase 3

~6760

cyclophosphamide

1994

Completed Phase 3

~8140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

88,291 Total Patients Enrolled

51 Trials studying Breast Cancer

27,944 Patients Enrolled for Breast Cancer

Bellicum PharmaceuticalsIndustry Sponsor

27 Previous Clinical Trials

1,310 Total Patients Enrolled

1 Trials studying Breast Cancer

113 Patients Enrolled for Breast Cancer

Claire E Dees, MD, MScPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center

Frequently Asked Questions

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

Has the iC9-CAR.B7-H3 T cell therapy received approval from the FDA?

"Our team at Power has evaluated the safety of iC9-CAR.B7-H3 T cells to be a 1 on our internal scale. This rating is based on the fact that this trial is currently in Phase 1, indicating that there is limited available data supporting both safety and effectiveness."

Answered by AI

Are there any ongoing opportunities for individuals to enroll in this active clinical trial?

"Information from clinicaltrials.gov shows that this particular research study is not actively seeking volunteers. While the trial was first listed on May 1, 2024, the most recent update occurred on March 28, 2024. Despite its current inactivity with regards to recruitment, it is noteworthy that there are currently a substantial number of 2785 alternative clinical trials actively seeking participants."

Answered by AI

What are the anticipated results that researchers hope to achieve through conducting this study?

"The principal objective of this research, to be evaluated within an up to 8-week period post Biological/Vaccine infusion, is Toxicity assessment via NCI-CTCAE criteria. Secondary measures encompass determining The recommended phase 2 dose (RP2D) CRS Grading through a modified 3+3 dose escalation method and iC9-CAR.B7-H3 T cell tolerability using ASTCT Consensus CRS Grading Criteria., Progression Free Survival (PFS) gauged from the onset of lymphodepletion chemotherapy before iC9-CAR.B7-H3 T cell administration until disease progression or demise per REC"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells

2024. "Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06347068.