What side effects are associated with this type of intervention?

Common treatments for glioblastoma, particularly those involving CAR T cell therapies like IL-8 receptor modified CD70 CAR T cell therapy, often result in side effects such as cytokine release syndrome (CRS), which includes symptoms like fever, nausea, headache, rash, rapid heartbeat, low blood pressure, and trouble breathing. Neurological toxicities, including confusion, seizures, and encephalopathy, are also frequent. Additionally, there can be on-target, off-tumor effects where the modified T cells attack normal tissues expressing the target antigen.

What prior FDA approvals exist?

The FDA has approved several treatments for glioblastoma, including temozolomide, bevacizumab, and tumor treating fields (Optune). While these treatments primarily involve chemotherapy, anti-angiogenesis, and electrical field therapy, there is growing interest in immunotherapies. Although specific FDA approvals for CAR T cell therapies targeting glioblastoma are not yet established, investigational approaches like IL-8 receptor modified CD70 CAR T cell therapy represent a promising frontier. These therapies involve engineering T cells to target specific antigens on glioblastoma cells, aiming to enhance the immune system's ability to combat the tumor.

What other types of research exist?

Promising novel alternatives to IL-8 receptor modified CD70 CAR T cell therapy for glioblastoma patients include: 1) Other CAR T cell therapies targeting different antigens such as EGFRvIII or HER2. 2) Immune checkpoint inhibitors like nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4), which have shown efficacy in various cancers and are being explored for glioblastoma. 3) Oncolytic virus therapies, which use genetically modified viruses to selectively infect and kill cancer cells. 4) Personalized cancer vaccines that stimulate the patient's immune system to target glioblastoma-specific antigens.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days post-infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment where a patient's own immune cells are modified to better attack brain cancer cells. It targets adults with a specific type of brain cancer (glioblastoma) that shows a certain marker (CD70). The modified cells are designed to recognize and kill the cancer more effectively. CD70 is a protein that is usually limited in normal tissue but appears in various cancers.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days post-infusion

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

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

Primary study objectives

Glioblastoma

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Chimeric Antigen Receptor (CAR) T cell therapy, such as the IL-8 receptor modified CD70 CAR T cell therapy, involves genetically engineering a patient's T cells to express receptors specific to antigens on glioblastoma cells, like CD70. These modified T cells can then recognize and attack the cancer cells more effectively. This approach is significant for glioblastoma patients as it offers a targeted treatment option that can potentially overcome the limitations of traditional therapies, such as chemotherapy and radiation, which often fail to fully eradicate the tumor and can cause significant side effects. By focusing on specific tumor antigens, CAR T cell therapy aims to improve treatment efficacy and patient outcomes.

The Landscape of Novel Therapeutics and Challenges in Glioblastoma Multiforme: Contemporary State and Future Directions.Role of Chimeric Antigen Receptor T Cell Therapy in Glioblastoma Multiforme.Genetically Engineered T-Cells for Malignant Glioma: Overcoming the Barriers to Effective Immunotherapy.