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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

Must not have

History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)

Receipt of bevacizumab within 3 months prior to physician-investigator confirmation of eligibility

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

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.

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.

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.

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I can care for myself but may need occasional help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to some ingredients in the study medication.

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I have not received bevacizumab in the last 3 months.

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I have severe limitations due to heart problems.

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I have an active hepatitis B or C infection.

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I do not have any active, uncontrolled infections.

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I am on strong medication for an autoimmune disease, but it's not a neurological one.

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My tumor is mainly in my brain stem or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

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

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

Secondary study objectives

Duration of response (DOR)

Frequency of manufacturing failures

Objective Response Rate (ORR)

+1 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.

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tmunity TherapeuticsIndustry Sponsor

6 Previous Clinical Trials

120 Total Patients Enrolled

Gilead SciencesIndustry Sponsor

1,098 Previous Clinical Trials

860,451 Total Patients Enrolled

3 Trials studying Glioblastoma

561 Patients Enrolled for Glioblastoma

University of PennsylvaniaLead Sponsor

2,053 Previous Clinical Trials

43,013,109 Total Patients Enrolled

7 Trials studying Glioblastoma

178 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

~2 spots leftby Dec 2024

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