Study on Drug Resistant Immunotherapy with Gene Modified T Cells and Chemotherapy for Glioblastoma

Sponsor: In8bio Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05664243

Provider View

This clinical trial is testing a new treatment that combines gene-modified immune cells with standard chemotherapy to see if it can safely and effectively delay the return of glioblastoma, a type of brain cancer.

Patient Parameters

Program Overview

This study is exploring a new treatment for glioblastoma, a type of brain cancer, using genetically modified immune cells called gamma-delta T cells. These cells are designed to resist the effects of chemotherapy, allowing them to be used alongside the standard chemotherapy drug temozolomide (TMZ). The goal is to see if this combination can safely delay the cancer's return in patients with newly diagnosed or recurrent glioblastoma.

Description

This clinical trial involves a new treatment using genetically modified gamma-delta T cells, known as DeltEx Drug Resistant Immunotherapy (DRI), combined with the chemotherapy drug temozolomide (TMZ). Gamma-delta T cells are a type of immune cell that can help the body recognize and attack cancer cells. In this study, these cells are modified to resist being destroyed by chemotherapy, allowing them to be used together with TMZ, which is the standard treatment for glioblastoma.

The study has four groups for patients with either newly diagnosed or returning glioblastoma. In one group, patients will receive DRI cells made from their own cells. In other groups, patients will receive DRI cells made from donor cells. Patients will undergo surgery to remove their tumor and have a special catheter placed to deliver the DRI cells directly to the tumor site.

After surgery, patients will receive chemotherapy and radiation for six weeks, followed by a break. Then, they will receive maintenance therapy, which includes five days of chemotherapy every 28 days for six cycles. The DRI cells will be infused on the first day of each cycle through the catheter. Patients will be monitored for side effects and followed for up to 15 years or until the cancer progresses or they leave the study.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of IDH-wild type glioblastoma.
  • For certain groups, must have completed no more than one standard therapy for glioblastoma and not have received prior Avastin® therapy unless for edema management.
  • For other groups, must have newly diagnosed glioblastoma.
  • Must have a partially matched donor for the DRI cells.
  • Must have MRI features suggesting recurrent malignant glioma for certain groups.
  • Agree to have a Rickham catheter placed.
  • Be 18 years or older.
  • Have a performance status score of 70% or higher.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control.
  • Men and women must agree to use two methods of birth control or be surgically sterile or abstain from heterosexual activity during the study.

Exclusion Criteria

  • Have received vaccinations or surgery shortly before cell collection.
  • Have had cellular or gene therapy recently or are receiving other investigational agents.
  • Have not recovered from previous treatment side effects.
  • Have had prior allogeneic therapy or a second active cancer.
  • Have a contraindication to placing a Rickham catheter.
  • Have a history of certain brain infections or conditions.
  • Have uncontrolled illness or conditions that prevent surgery.
  • Have allergies to certain medications.
  • Have a history of HIV, active hepatitis, or autoimmune conditions.

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