← Back to Search

CAR T-cell Therapy

CAR-T Cell Therapy for Relapsing Breast Cancer

Phase 1

Recruiting

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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Toxicity: Cytokine Release Syndrome (CRS)

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

Toxicity: NCI-CTCAE

Secondary study objectives

Duration of Response (DOR)

Objective response rate

Overall Survival (OS)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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