CAR.B7-H3T cells infusion for Glioblastoma Multiforme (GBM)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lineberger Comprehensive Cancer Center, Chapel Hill, NC
Glioblastoma Multiforme (GBM)+1 More
CAR.B7-H3T cells infusion - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to test the safety of using T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (CAR.B7-H3T cells) in patients with glioblastoma. CAR.B7-H3T cells treatment has not been tested in humans and is not an approved treatment by the Food and Drug Administration for glioblastoma.

Eligible Conditions

  • Glioblastoma Multiforme (GBM)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Glioblastoma Multiforme (GBM)

Study Objectives

4 Primary · 5 Secondary · Reporting Duration: Up to 5 years

Up to 10 weeks
Cytokine Release Syndrome
Neurotoxicity
Number of participants with adverse event
Safety and tolerability
Up to 12 months
Duration of Response (DOR)
Progression Free Survival (PFS)
Up to 4 weeks
Identification of Recommended phase 2 dose (RP2D)
Objective Response Rate (ORR)
Up to 5 years
Overall Survival (OS)

Trial Safety

Safety Progress

1 of 3

Other trials for Glioblastoma Multiforme (GBM)

Trial Design

1 Treatment Group

Single Arm
1 of 1
Experimental Treatment

36 Total Participants · 1 Treatment Group

Primary Treatment: CAR.B7-H3T cells infusion · No Placebo Group · Phase 1

Single Arm
Drug
Experimental Group · 1 Intervention: CAR.B7-H3T cells infusion · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Closest Location: Lineberger Comprehensive Cancer Center · Chapel Hill, NC
2007First Recorded Clinical Trial
1 TrialsResearching Glioblastoma Multiforme (GBM)
22 CompletedClinical Trials

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
303 Previous Clinical Trials
71,311 Total Patients Enrolled
Yasmeen Rauf, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of recurrent supratentorial- or infratentorial GBM based on Response assessment in neuro-oncology criteria (RANO) MRI criteria.
You have received at least 4005 cGy of radiation with concurrent temozolomide.
You are willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.