Gamma-Delta T Cell Therapy for Glioblastoma

(DRI Trial)

Overseen By Thiru Pillay, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Alabama at Birmingham

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

22 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being conducted to find out if the safety and tolerability of an experimental cell therapy is safe to administer to patients with a newly diagnosed glioblastoma multiforme (GBM) in combination with temozolomide (TMZ).

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on any other investigational agents or have received certain treatments like cellular immunotherapy or gene therapy within 6 weeks before the study.

What data supports the effectiveness of the treatment DRI cell therapy for glioblastoma?

Research shows that gamma-delta T cells, a type of immune cell, can effectively target and kill glioblastoma cells in lab studies and animal models. These cells have been shown to recognize and attack tumor cells, suggesting they could be a promising treatment option for glioblastoma. ^{1 2 3 4 5}

Is gamma-delta T cell therapy safe for humans?

Research suggests that gamma-delta T cell therapy is generally safe for brain tumor patients, even those who have undergone standard treatments like radiation and chemotherapy. Studies have shown that these cells do not harm normal brain tissue, indicating a favorable safety profile. ^{1 2 3 4 5}

How is the Gamma-Delta T Cell Therapy treatment different from other treatments for glioblastoma?

Gamma-Delta T Cell Therapy is unique because it uses a specific type of immune cell, gamma-delta T cells, which are known for their ability to recognize and attack a wide range of tumor cells, including those in glioblastoma. This therapy involves injecting these cells directly into the brain, where they can patrol and eliminate cancer cells, offering a novel approach compared to traditional treatments like chemotherapy and radiation. ^{1 2 3 4 5}

Research Team

Louis B Nabors, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

Adults over 18 with newly diagnosed glioblastoma multiforme (GBM) who've finished standard treatment and are set for maintenance therapy. They need good organ/marrow function, a Karnofsky Performance Status ≥70%, and an MRI suggesting malignant glioma. Excluded are those with HIV, prior transplants, other GBM treatments, unstable health conditions, or women who are pregnant/breastfeeding.

Inclusion Criteria

My organ and bone marrow functions are within normal ranges.

My MRI suggests I might have a serious brain tumor.

I've finished initial treatment for brain cancer and am ready for ongoing therapy.

Exclusion Criteria

I do not have any severe illnesses or mental health issues that would prevent me from following the study's requirements.

I needed more steroids recently before getting a specific cell therapy.

I have had encephalitis, multiple sclerosis, or another brain infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Subjects undergo surgical resection to remove the tumor and have a Rickham catheter placed

1 week

1 visit (in-person)

Apheresis and Cell Synthesis

Apheresis procedure to collect PBMCs for DRI γδ T cell synthesis

1 week

1 visit (in-person)

Initial Treatment

6 weeks of chemotherapy with TMZ and radiation

6 weeks

Maintenance Treatment

6 cycles of TMZ with DRI γδ T cell injections through the Rickham catheter

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Long-term Follow-up

Monitoring for disease progression and overall survival

Up to 15 years

Treatment Details

Interventions

• DRI cell therapy

Trial Overview The trial is testing the safety of DRI γδ T cell therapy combined with temozolomide in patients with new GBM. It's experimental and involves two parts: initial surgery to place a device for drug delivery and then receiving the actual cell therapy.

Participant Groups

Group I: DRI cell therapy Experimental Treatment 1 Intervention

The only arm will receive the DRI modified gamma delta T cells following standard therapy with radiation and temozolomide chemotherapy concurrent.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

In8bio Inc.

Industry Sponsor

Trials

3

Recruited

60+

References

1. United States pubmed.ncbi.nlm.nih.gov

Human allogenic γδ T cells kill patient-derived glioblastoma cells expressing high levels of DNAM-1 ligands. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Human gamma-delta (γδ) T cell therapy for glioblastoma: A novel alternative to overcome challenges of adoptive immune cell therapy. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A simple method for the propagation and purification of gamma delta T cells from the peripheral blood of glioblastoma patients using solid-phase anti-CD3 antibody and soluble IL-2. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

The safety of allogeneic innate lymphocyte therapy for glioma patients with prior cranial irradiation. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Stereotaxic administrations of allogeneic human Vγ9Vδ2 T cells efficiently control the development of human glioblastoma brain tumors. [2021]