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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

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.Check my eligibility
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.See study design
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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~through study completion, on average one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, on average one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary: Highest safe dose frequency or maximally planned dose, if no dose-limiting toxicity observed.
Secondary outcome measures
Assessment of biological activity
Overall survival
Time to progression

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
1,599 Previous Clinical Trials
2,287,899 Total Patients Enrolled
In8bio Inc.Industry Sponsor
2 Previous Clinical Trials
158 Total Patients Enrolled
Louis B Nabors, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
4 Previous Clinical Trials
193 Total Patients Enrolled

Media Library

DRI cell therapy (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04165941 — Phase 1
Brain Tumor Research Study Groups: DRI cell therapy
Brain Tumor Clinical Trial 2023: DRI cell therapy Highlights & Side Effects. Trial Name: NCT04165941 — Phase 1
DRI cell therapy (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04165941 — Phase 1
~2 spots leftby Dec 2024
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