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CAR T-cell Therapy

CAR T-cell Therapy for Glioblastoma

Phase 1
Recruiting
Led By Stephen Bagley, MD, MSCE
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with glioblastoma, IDH-wildtype that has recurred following prior radiotherapy
Male or female age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights

Study Summary

This trial tests safety and effectiveness of new cell therapy for glioblastoma brain tumors that have come back after treatment.

Who is the study for?
This trial is for adults over 18 with recurrent glioblastoma, IDH-wildtype, after radiotherapy. Candidates must have adequate organ function, EGFR-amplified tumors confirmed by specific tests, and agree to use birth control. Excluded are those with active hepatitis B/C, severe comorbidities, recent bevacizumab treatment, autoimmune diseases needing high-dose steroids or pregnant/nursing women.Check my eligibility
What is being tested?
The study is testing the safety of CART-EGFR-IL13Ra2 cells in patients whose glioblastoma has returned despite prior treatments. It's an early-phase trial where participants receive genetically modified T cells targeting two specific molecules on their cancer.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to modified T cell activity against the tumor which can affect normal tissues as well. Specific side effects aren't listed but typically involve flu-like symptoms, fatigue, and possible organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My glioblastoma has returned after radiation treatment.
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I am 18 years old or older.
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I have mild or no shortness of breath and my oxygen level is above 92% without assistance.
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My tumor is EGFR positive, as confirmed by NeoGenomics.
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My kidneys work well enough, not requiring dialysis.
Select...
I can care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 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
Determination of maximum tolerated dose assessed by collection of adverse events as graded by CTCAE.
Number of Subjects with treatment related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Number of subjects with dose-limiting toxicities
Secondary outcome measures
Duration of response (DOR)
Frequency of manufacturing failures
Objective Response Rate (ORR)
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose Level 3Experimental Treatment1 Intervention
Cohort 3 (N = 3-6): will receive a single fixed dose of 5x10^7 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0.
Group II: Dose Level 2Experimental Treatment1 Intervention
Cohort 2 (N = 3-6): will receive a single fixed dose of 2.5x10^7 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0.
Group III: Dose Level 1Experimental Treatment1 Intervention
Cohort 1 (N = 3-6): will receive a single fixed dose of 1x10^7 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0.
Group IV: Dose Level -1Experimental Treatment1 Intervention
Cohort-1 (N = 3-6): will receive a single fixed dose of 5x10^6 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0.

Find a Location

Who is running the clinical trial?

Tmunity TherapeuticsIndustry Sponsor
6 Previous Clinical Trials
131 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,085 Previous Clinical Trials
848,127 Total Patients Enrolled
3 Trials studying Glioblastoma
561 Patients Enrolled for Glioblastoma
University of PennsylvaniaLead Sponsor
2,015 Previous Clinical Trials
42,874,008 Total Patients Enrolled
7 Trials studying Glioblastoma
187 Patients Enrolled for Glioblastoma

Media Library

CART-EGFR-IL13Ra2 Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05168423 — Phase 1
Glioblastoma Research Study Groups: Dose Level 3, Dose Level 1, Dose Level -1, Dose Level 2
Glioblastoma Clinical Trial 2023: CART-EGFR-IL13Ra2 Cells Highlights & Side Effects. Trial Name: NCT05168423 — Phase 1
CART-EGFR-IL13Ra2 Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05168423 — Phase 1
~5 spots leftby Dec 2024
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