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Cell Therapy
Gamma-Delta T Cell Therapy for Glioblastoma (DRI Trial)
Phase 1
Waitlist Available
Led By Louis B Nabors, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have organ and marrow function within specified limits.
Must have completed a standard temozolomide and radiotherapy treatment as described in Part A and be eligible to receive maintenance therapy with temozolomide (consistent with NCCN guidelines for newly diagnosed GBM and maintenance therapy).
Must not have
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other medical condition that precludes surgery. Also, psychiatric illness/social situations that would limit compliance with study requirements.
Prior history of encephalitis, multiple sclerosis, or other CNS infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, on average one year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing an experimental cell therapy to see if it is safe to give to patients with newly diagnosed glioblastoma multiforme, in combination with the standard treatment of temozolomide.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects aren't detailed but may include typical reactions to cellular therapies such as immune responses leading to inflammation, infusion-related symptoms like fever or chills, fatigue from marrow suppression, or complications related to brain surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My organ and bone marrow functions are within normal ranges.
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I've finished initial treatment for brain cancer and am ready for ongoing therapy.
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I am 18 years old or older.
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I am able to care for myself and perform normal activities.
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My diagnosis of glioblastoma has been confirmed by lab tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any severe illnesses or mental health issues that would prevent me from following the study's requirements.
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I have had encephalitis, multiple sclerosis, or another brain infection.
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I cannot have a device placed in my brain due to medical reasons.
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I have never had an organ or bone marrow transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, on average one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, on average one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary: Highest safe dose frequency or maximally planned dose, if no dose-limiting toxicity observed.
Secondary study objectives
Assessment of biological activity
Overall survival
Time to progression
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: DRI cell therapyExperimental Treatment1 Intervention
The only arm will receive the DRI modified gamma delta T cells following standard therapy with radiation and temozolomide chemotherapy concurrent.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,354 Total Patients Enrolled
In8bio Inc.Industry Sponsor
2 Previous Clinical Trials
42 Total Patients Enrolled
Louis B Nabors, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
4 Previous Clinical Trials
77 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I cannot have a device placed in my brain due to medical reasons.My organ and bone marrow functions are within normal ranges.I have never had an organ or bone marrow transplant.My MRI suggests I might have a serious brain tumor.I've finished initial treatment for brain cancer and am ready for ongoing therapy.I am 18 years old or older.You are expected to live for at least 12 more weeks.I am able to care for myself and perform normal activities.You are allergic or very sensitive to certain medications.I have not received treatment for GBM before joining Part A of the study.Women who could become pregnant must use approved birth control methods.My diagnosis of glioblastoma has been confirmed by lab tests.
Research Study Groups:
This trial has the following groups:- Group 1: DRI cell therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.