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CAR T-cell Therapy

Chimeric Antigen Receptors for Recurrence

Phase 1

Waitlist Available

Led By Linda Van Le, MD

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 aims to test a new treatment using modified immune cells to treat ovarian cancer that has returned after standard therapy. The treatment is experimental and not yet approved by the FDA. Researchers want to determine the

Who is the study for?

This trial is for individuals with ovarian cancer that has returned after standard treatment. Participants must have sufficient T cells to modify, and meet specific health criteria not detailed here.Check my eligibility

What is being tested?

The study tests a new therapy using modified T cells (iC9-CAR.B7-H3) after chemotherapy with Fludarabine and Cyclophosphamide. It's in two parts: cell collection/modification, then infusion post-chemotherapy.See study design

What are the potential side effects?

Potential side effects include reactions at the infusion site, flu-like symptoms, changes in blood counts, increased risk of infection, and possibly others not listed.

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

Overall Survival (OS)

Progression Free Survival (PFS)

The disease control rate (DCR)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Chimeric Antigen ReceptorsExperimental Treatment3 Interventions

blood 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

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

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

88,306 Total Patients Enrolled

Linda Van Le, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center

2 Previous Clinical Trials

32 Total Patients Enrolled

Frequently Asked Questions

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

Is this clinical trial currently accepting new participants?

"The information provided on clinicaltrials.gov indicates that the current trial is not actively seeking participants. This particular study was initially listed on March 1, 2024, and last updated on March 8, 2024. Despite this trial being closed for recruitment, there are currently 665 other trials open to enrolling new subjects at present."

Answered by AI

What are the potential risks associated with Chimeric Antigen Receptor therapy in individuals receiving treatment?

"Based on our assessment at Power, the safety rating of Chimeric Antigen Receptors is graded as 1 owing to its Phase 1 trial status, indicating restricted evidence supporting both safety and efficacy."

Answered by AI

What are the primary objectives of this scientific study?

"The primary objective of this investigation, to be assessed within a timeframe extending up to 4 weeks, is the evaluation of Toxicity: Cytokine Release Syndrome (CRS). Secondary endpoints encompass Progression Free Survival (PFS), defined as the duration from initiation of lymphodepleting chemotherapy before iC9-CAR.B7-H3 T cell infusion until progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 or mortality; Radiographic response evaluated by RECIST 1.1 criteria indicating Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30%"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells

2024. "Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06305299.