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CAR T-cell Therapy

Cohort 1: Starting Dose (5 x 10^7 CAR+ cells) for Glioblastoma

Phase 1

Recruiting

Research Sponsored by Hideho Okada, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate pulmonary function, defined as no evidence of dyspnea at rest and pulse oximetry > 92% while breathing room air

Pathological criteria: EGFRvIII+ GBM from most recent surgery, confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certified lab using a next-generation sequencing panel

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 96 weeks

Awards & highlights

Study Summary

This trial is testing a new treatment called E-SYNC for adults with a type of brain cancer called glioblastoma. The treatment involves using the patient's own immune cells that have been modified to

Who is the study for?

Adults with a specific mutation in their epidermal growth factor receptor (EGFRvIII) who have been diagnosed with glioblastoma, a type of brain cancer. Participants must meet certain health standards and not be receiving other treatments that could interfere.Check my eligibility

What is being tested?

The trial is testing E-SYNC T Cells, which are engineered immune cells designed to target cancer cells in the brain. It's an early-stage study to see if this treatment is safe and how well it works.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal cells, flu-like symptoms, fatigue, fever, and risks associated with cell therapies.

Eligibility Criteria

Inclusion Criteria

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

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I can breathe normally without feeling short of breath and my oxygen level is above 92%.

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My latest surgery confirmed I have EGFRvIII+ GBM.

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My cancer has a low or no MGMT gene methylation.

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I am 18 years old or older.

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My kidney function, measured by creatinine clearance, is normal or near normal.

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

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I have completed the standard radiotherapy treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 96 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 96 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 96 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Proportion of participants reporting treatment-emergent adverse events

Secondary outcome measures

Percentage of participants who successfully receive E-SYNC T cells

The percentage of primed E-SYNC T (Cohort 2 only) cells in TIL versus PBMC will be evaluated

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 2: Tissue analysis cohortExperimental Treatment5 Interventions

Participants with EGFRvIII+ glioblastoma recurrence after initial non-investigational, chemoradiation who need surgery will have the EGFRvIII H-scored based on digital image analysis of EGFRvIII immunohistochemistry (IHC) slides, with the score denoting both extent of and intensity of positive staining. Participants with an H-score of >=250 will undergo leukapheresis for manufacturing of E-SYNC T cells at the maximum tolerated dose, or recommended dose based on results from cohort 1 more than 2 weeks after completion of their non-investigational, standard of care radiation therapy. Participants will receive a single infusion of drug product (DP) on day 0 and will be admitted to the hospital for surgical resection (non-investigational) between days 14 and 28, and monitored for safety, presence of and possible synNotch > CAR-T priming of the DP in the peripheral blood, and anti-tumor response of E-SYNC T cells.

Group II: Cohort 1: Starting Dose (5 x 10^7 CAR+ cells)Experimental Treatment4 Interventions

Participants with newly diagnosed EGFRvIII+ GBM with unmethylated MGMT promotor status will undergo leukapheresis for manufacturing of E-SYNC T cells at least 2 weeks after completion of tnon-interventional, standard of care radiation therapy. Participants receive cyclophosphamide IV and fludarabine IV on days -5, -4, and -3 and then receive E-SYNC T cells IV on day 0. Participants will receive a single infusion of drug product (DP) (5 x 10^7 CAR+ T cells) and be monitored for safety, presence of and possible synNotch > CAR-T priming of the DP in the peripheral blood.

Group III: Cohort 1: Dose-escalation (1.5 x 10^8 CAR+ cells)Experimental Treatment4 Interventions

If there are no dose-limiting toxicities in the starting dose cohort, participants with newly diagnosed EGFRvIII+ GBM with unmethylated MGMT promotor status will undergo leukapheresis for manufacturing of E-SYNC T cells at least 2 weeks after completion of tnon-interventional, standard of care radiation therapy. Participants receive cyclophosphamide IV and fludarabine IV on days -5, -4, and -3 and then receive E-SYNC T cells IV on day 0. Participants will receive a single infusion of drug product (DP) (1.5 x 10^8 CAR+ T cells) and be monitored for safety, presence of and possible synNotch > CAR-T priming of the DP in the peripheral blood.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leukapheresis

2016

Completed Phase 2

~690

Surgical resection

2021

Completed Phase 2

~920

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hideho Okada, MD, PhDLead Sponsor

California Institute for Regenerative Medicine (CIRM)OTHER

65 Previous Clinical Trials

3,161 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,680 Previous Clinical Trials

40,928,504 Total Patients Enrolled

323 Trials studying Glioblastoma

23,128 Patients Enrolled for Glioblastoma

Frequently Asked Questions

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

Are individuals currently eligible to participate in this ongoing research study?

"According to the information available on clinicaltrials.gov, this trial is not currently open for participant enrollment. The initial posting of the trial was on March 1st, 2024, and it was last updated on December 15th, 2023. However, there are a total of 479 other ongoing studies actively seeking patients at this time."

Answered by AI

Has the initial dose of Cohort 1, containing 5 x 10^7 CAR+ cells, received approval from the FDA?

"Given that this trial is in Phase 1, meaning there is limited data supporting both safety and efficacy, our team at Power rates the safety of Cohort 1: Starting Dose (5 x 10^7 CAR+ cells) as a score of 1."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells

Hideho Okada, MD, PhD 2024. "Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06186401.

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