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CAR T-cell Therapy

CAR T Cell Therapy for Glioblastoma (IMPACT Trial)

Phase 1
Recruiting
Led By Ashley Ghiaseddin, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate renal function: BUN ≤ 25 mg/dl, Creatinine ≤ 1.7 mg/dl
Surgical resection of tumors with less than 3cm x 3cm (9 cm2) residual enhancing tumor as a product of longest perpendicular planes by MRI (biopsy only subjects are not eligible for this study)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days post-infusion
Awards & highlights

IMPACT Trial Summary

This trial is to see if it's safe to use IL-8 receptor modified patient-derived activated CD70 CAR T cells to treat brain cancer.

Who is the study for?
Adults over 18 with newly-diagnosed, high-grade glioblastoma without prior brain tumors, who've had a recent surgical resection leaving less than 9 cm2 tumor. They must have CD70 positive and MGMT-unmethylated tumors, good liver and kidney function, stable blood counts, no severe illnesses or immune conditions that could interfere with the treatment. Women of childbearing age must test negative for pregnancy and agree to contraception.Check my eligibility
What is being tested?
The trial is testing a new therapy using the patient's own T cells that are modified to target IL-8 receptor in CD70+ glioblastoma cells. It aims to evaluate if this personalized cellular therapy is safe and can be feasibly produced for each participant.See study design
What are the potential side effects?
While specific side effects aren't listed here, CAR T cell therapies often include flu-like symptoms, fatigue, fever, difficulty breathing or shortness of breath; there may also be risks related to changes in blood pressure or heart rate.

IMPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is good, with normal BUN and creatinine levels.
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My tumor was surgically removed and is smaller than 3cm x 3cm on MRI.
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My tumor is located in the upper part of my brain.
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I have been newly diagnosed with a high-grade brain tumor without any previous brain tumor history.
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I am able to care for myself but may not be able to do active work.
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My liver tests are within the required limits.
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My cancer tests positive for CD70.
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I am 18 years old or older.

IMPACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days post-infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days post-infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Glioblastoma
Glioblastoma

IMPACT Trial Design

1Treatment groups
Experimental Treatment
Group I: 8R-70CAR T cellsExperimental Treatment1 Intervention
Cohort 1 will receive 1 x 10^6 cells/kg. Cohort 2 will receive 1 x 10^7 cells/kg. Cohort 3 will receive 1 x 10^8 cells/kg. Cohort 4 will receive Cy/Flu + CAR T cells at established maximum tolerated dose.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,338 Previous Clinical Trials
715,338 Total Patients Enrolled
10 Trials studying Glioblastoma
456 Patients Enrolled for Glioblastoma
United States Department of DefenseFED
859 Previous Clinical Trials
225,613 Total Patients Enrolled
1 Trials studying Glioblastoma
13 Patients Enrolled for Glioblastoma
AM Rosen FoundationUNKNOWN

Media Library

Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05353530 — Phase 1
Glioblastoma Research Study Groups: 8R-70CAR T cells
Glioblastoma Clinical Trial 2023: Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells Highlights & Side Effects. Trial Name: NCT05353530 — Phase 1
Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05353530 — Phase 1

Frequently Asked Questions

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

Are there any unfilled vacancies for participants in this research?

"The details hosted on clinicaltrials.gov indicate that this trial has concluded its search for participants, with the last update occuring on July 29th 2021. Yet, there still remains 442 other medical studies actively accepting patients at present time."

Answered by AI

Is it possible to join this clinical research endeavor?

"This medical trial is currently enrolling 18 persons with glioblastoma ranging from 18 to 80 years of age. For eligibility, patients must fulfil the following criteria: Age ≥18; Supratentorial growth pattern; MGMT-unmethylated & CD70 positive (≥20%, 1+); Low/Moderate/High level expression; Negative score for 0 staining intensity; No prior brain tumours as per WHO Grade IV glioma histopathology or molecular assessment (secondary GBM not accepted); At least 20% of cells scoring 1+ staining intensity (>20%, 1+).."

Answered by AI

Is the age threshold for participation in this study restricted to below 20 years old?

"Eligibility for this clinical trial requires patients to be between 18 and 80 years old. Separately, there are 35 trials that offer treatments exclusively to those below the age of consent as well as 416 studies targeting elderly individuals over 65."

Answered by AI

What risk factors should be taken into account when considering Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cell treatments?

"Clinical data on the safety and efficacy of Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells is limited, so our team at Power assigned it a score of 1."

Answered by AI
~12 spots leftby Dec 2027