What side effects are associated with this type of intervention?

Common treatments for Glioblastoma, particularly those enhancing the immune response such as autologous activated T cells, often have side effects including Grade 3 or higher toxicities, serious adverse events, and treatment-related toxicities as per the National Cancer Institute Common Toxicity Criteria. These can include fatigue, headaches, nausea, and potential immune-related adverse effects such as inflammation or autoimmunity. Other general side effects of Glioblastoma treatments like chemotherapy and radiation can include hair loss, skin irritation, and hematologic toxicities.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma that focus on enhancing the immune response. One notable approval is for pembrolizumab, an immune checkpoint inhibitor that targets PD-1, enhancing the body's immune response against cancer cells. Another significant approval is for bevacizumab, an anti-VEGF antibody that, while primarily targeting angiogenesis, also has immunomodulatory effects. These treatments, along with ongoing research into autologous activated T cells, represent a growing focus on leveraging the immune system to combat Glioblastoma.

What other types of research exist?

Promising novel alternatives to Autologous Activated T Cells for Glioblastoma patients include: 1) Immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1 and anti-CTLA-4 therapies), which help to enhance the body's immune response against tumor cells. 2) Chimeric Antigen Receptor (CAR)-T cell therapies, which are engineered to specifically target and kill cancer cells. 3) Combination therapies involving radiation and immunotherapy to improve the antitumor immune response. 4) Experimental vaccines targeting tumor-specific antigens to stimulate a robust immune response. These alternatives are currently being evaluated in clinical trials and show potential for improving outcomes in Glioblastoma patients.

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CAR T-cell Therapy

Activated T Cells for Brain Cancer

Phase 1

Waitlist Available

Led By Jeremy Rudnick, MD

Research Sponsored by Jeremy Rudnick, M.D

Eligibility Criteria Checklist

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

Must have

Recurrent glioblastoma

HLA-A1 and HLA-A2 positive

Must not have

Known history of Hepatitis B or Hepatitis C

Clinically significant pulmonary, cardiac or other systemic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline visit and at time of recurrence. assessed up to 3 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment where a patient's own immune cells are enhanced to better fight cancer. It aims to find out if this treatment is safe and how well it works for cancer patients.

Who is the study for?

This trial is for individuals with recurrent glioblastoma who are HLA-A1 and HLA-A2 positive and have had a complete resection of their tumor. It's not suitable for those with HIV/AIDS, hepatitis B or C, allergies to DMSO or gentamicin, significant heart or lung disease, or active infections needing treatment.

What is being tested?

The study tests the safety and tolerability of autologous activated T cells (ATCs) in patients with recurrent glioblastoma. It aims to find the maximum tolerated dose while monitoring serious adverse events and treatment-related toxicities using NCI CTCAE V5 criteria.

What are the potential side effects?

Potential side effects include Grade 3 or higher toxicities such as severe immune reactions, infusion-related complications, and possible worsening of underlying conditions due to ATC therapy as per NCI CTCAE Version 5 guidelines.

Eligibility Criteria

Inclusion Criteria

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

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My brain cancer has come back after treatment.

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I am HLA-A1 and HLA-A2 positive.

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My tumor has been completely removed surgically.

Exclusion Criteria

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

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I have a history of Hepatitis B or C.

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I have a serious lung, heart, or other major health issue.

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I have HIV/AIDS or another serious health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline visit and at time of recurrence. assessed up to 3 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline visit and at time of recurrence. assessed up to 3 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline visit and at time of recurrence. assessed up to 3 years. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Grade 3 or higher toxicities, number of serious adverse events, and the number of treatment-related toxicities to find the maximum tolerated dose

Secondary study objectives

Health-related quality of life parameters

Immune Response

Overall Response Rate (ORR)

+1 more

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: Activated T cellsExperimental Treatment1 Intervention

0 / 6Eligibility criteria met

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

Common treatments for Glioblastoma include surgery, radiation therapy, and chemotherapy with temozolomide. These treatments aim to remove or reduce the tumor and kill cancer cells. Recently, immunotherapy, such as the use of autologous activated T cells, has gained attention. This approach involves enhancing the patient's immune system to recognize and attack cancer cells more effectively. For Glioblastoma patients, this is crucial as it offers a targeted method to combat the tumor, potentially leading to better outcomes and fewer side effects compared to traditional therapies.

Irradiation to Improve the Response to Immunotherapeutic Agents in Glioblastomas.