← Back to Search

CAR T-cell Therapy

CAR-T Cell Therapy for Glioblastoma

Phase 1

Recruiting

Led By Yasmeen Rauf, 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

No current or previous exposure to antiangiogenic agents, such as bevacizumab.

Karnofsky score of > 60%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing if it's safe to use CAR.B7-H3T cells, a treatment for glioblastoma that hasn't been tested on humans before.

Who is the study for?

This trial is for adults with recurrent glioblastoma who've had radiation and temozolomide treatment, but no antiangiogenic agents like bevacizumab. They must not have widespread disease down the spinal cord or previous CAR-T therapy, and should be able to follow study procedures. Women of childbearing age and men with partners must agree to use contraception.Check my eligibility

What is being tested?

The trial is testing a new potential treatment called CAR.B7-H3T cells infusion for glioblastoma patients. This involves modifying T cells to target cancer cells more effectively. It's an early-stage trial focusing on safety since this approach hasn't been tried in humans before.See study design

What are the potential side effects?

Since this is the first time CAR.B7-H3T cell infusion is being tested in humans, specific side effects are unknown but may include immune reactions, fever, fatigue, headache, or other symptoms related to changes in blood counts or immune system activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have never been treated with drugs that stop the formation of blood vessels in cancer.

Select...

I am able to care for myself but may not be able to do active work.

Select...

I have a recurring brain tumor (GBM) not spread to the spinal cord, confirmed by MRI.

Select...

I have completed radiation therapy with a specific drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Syndrome

Neurotoxicity

Number of participants with adverse event

Secondary outcome measures

Duration of Response (DOR)

Identification of Recommended phase 2 dose (RP2D)

Objective Response Rate (ORR)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

CAR.B7-H3 T cells: Subjects with refractory or recurrent glioblastoma multiforme, have cells collected following their initial surgical resection to manufacture CAR.B7-H3 T cells, preferably before initiation of adjuvant chemoradiation.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

88,297 Total Patients Enrolled

1 Trials studying Glioblastoma

10 Patients Enrolled for Glioblastoma

Yasmeen Rauf, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center

Media Library

CAR.B7-H3T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05366179 — Phase 1

Glioblastoma Research Study Groups: Single Arm

Glioblastoma Clinical Trial 2023: CAR.B7-H3T cells Highlights & Side Effects. Trial Name: NCT05366179 — Phase 1

CAR.B7-H3T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05366179 — 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 enrollment phase of this experiment currently ongoing?

"The data available on clinicaltrials.gov suggests that the medical trial is actively seeking participants for participation; it was first posted to the site on September 2nd 2022 and last revised on October 25th 2022."

Answered by AI

Have the regulatory bodies authorized CAR.B7-H3T cells infusion?

"CAR.B7-H3T cells infusion is rated a 1 on the safety scale due to its relative lack of data in terms of both efficacy and precautionary measures - it currently sits at Phase 1 trial status."

Answered by AI

What tangible outcomes is this experiment attempting to manifest?

"This clinical trial seeks to measure the number of participants with adverse events as its primary outcome over a 10-week period. Secondary objectives include measuring Progression Free Survival (PFS), determining the Recommended Phase 2 Dose (RP2D), and tracking Duration of Response (DOR). The PFS is defined as the time from initial CAR.B7-H3 T cell infusion until disease progression or death, while RP2D will be calculated by employing a modified 3+3 dose-finding rule, and DOR by calculating the duration between confirmed response and progressive disease."

Answered by AI

What is the upper limit of participants involved in this research project?

"Affirmative. The clinicaltrial.gov database shows that this medical trial, initially posted on September 2nd 2022, is actively seeking participants. 36 individuals need to be recruited from a single research site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc

2022. "Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05366179.

All > Glioblastoma High Point