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CAR T-cell Therapy
Gene-Modified T Cell Therapy for Glioblastoma
Phase 1 & 2
Recruiting
Led By Louis B Nabors, MD
Research Sponsored by In8bio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial tests if a cell therapy can delay cancer return in GBM patients when combined with standard chemo. If it works, it should be studied further.
Who is the study for?
This trial is for adults with newly diagnosed or recurrent glioblastoma who haven't had more than one standard therapy and no prior Avastin, unless for edema. They must be in good physical condition (Karnofsky Performance ≥ 70%), agree to use two birth control methods if of childbearing potential, and have a suitable donor for the cell therapy. Exclusions include recent vaccinations or surgery, unresolved treatment side effects, other cancers within two years (unless low risk), allergies to certain drugs, uncontrolled illnesses that affect study compliance or interpretation.Check my eligibility
What is being tested?
The trial tests genetically modified gamma-delta T cells from either the patient (autologous) or a donor (allogeneic) combined with temozolomide chemotherapy in patients with glioblastoma. The goal is to see if this experimental cell therapy can improve survival by at least 25% compared to current treatments.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune response due to gene-modified T cells such as inflammation in various organs, infusion-related reactions like fever or chills, and typical chemotherapy-associated risks including nausea, fatigue, blood disorders and increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Allogeneic Phase 1b, establishes the recommended phase 2 dose (RP2D) for phase 2 allogeneic arms and subject or product characteristics that will optimize manufacturing
Allogeneic Phase 2, Arm B confirmed recurrent glioblastoma, 9-month overall survival (OS)
Allogeneic Phase 2, Arm C newly diagnosed glioblastoma, 12-month overall survival (OS) rate
+1 moreSecondary outcome measures
Assessment of safety
Assessment of tolerability
Definition of product characteristics
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: 4) Allogeneic: Phase 2 Arm CExperimental Treatment1 Intervention
Arm C subjects with newly diagnosed disease will receive allogeneic derived, genetically modified gamma-delta T cells administered with maintenance temozolomide.
Group II: 3) Allogeneic: Phase 2 Arm BExperimental Treatment1 Intervention
Arm B subjects with relapsed disease will have allogeneic derived, genetically modified gamma-delta T cells administered with temozolomide
Group III: 2) Allogeneic: Phase 1bExperimental Treatment1 Intervention
Phase 1b subjects with relapsed disease will have allogeneic derived, genetically modified gamma-delta T cells administered with temozolomide
Group IV: 1) Autologous: Phase 2 Arm AExperimental Treatment1 Intervention
Arm A subjects with newly diagnosed disease will receive autologously derived, genetically modified gamma-delta T cells administered with maintenance temozolomide.
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Who is running the clinical trial?
In8bio Inc.Lead Sponsor
2 Previous Clinical Trials
59 Total Patients Enrolled
1 Trials studying Glioblastoma
21 Patients Enrolled for Glioblastoma
Louis B Nabors, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
4 Previous Clinical Trials
94 Total Patients Enrolled
3 Trials studying Glioblastoma
85 Patients Enrolled for Glioblastoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who can have children and have a recent negative pregnancy test.I am willing to have a Rickham catheter placed.I haven't had encephalitis, multiple sclerosis, or a CNS infection in the year before my brain cancer diagnosis.I received a vaccine or had surgery within the specified times before my leukapheresis collection.I am willing to have a Rickham catheter placed and kept in.I haven't had certain cancer treatments like immunotherapy or surgery in the weeks before joining the study.I am 18 years old or older.I have had a transplant, like bone marrow or solid organ, as treatment.My MRI suggests I might have a recurring brain tumor.My glioblastoma does not have IDH mutations.I am a woman who can have children and have a recent negative pregnancy test.I cannot have a device placed in my brain during surgery.I have a history of HIV, hepatitis, or an autoimmune condition.I am mostly able to care for myself.I've had only one standard treatment for glioblastoma, no Avastin® (unless for swelling), and can have surgery.I don't have any health issues that would stop me from having surgery or following the study's requirements.I still experience side effects from past treatments, but I don't have hair loss due to immune reasons.I have no active cancer besides my current diagnosis or have been cancer-free for 2 years.I have a new diagnosis of glioblastoma and haven't started treatment.I am using or willing to use two birth control methods or abstain from sex during the study.I am using or willing to use two birth control methods or abstain from sex during the study.
Research Study Groups:
This trial has the following groups:- Group 1: 4) Allogeneic: Phase 2 Arm C
- Group 2: 3) Allogeneic: Phase 2 Arm B
- Group 3: 1) Autologous: Phase 2 Arm A
- Group 4: 2) Allogeneic: Phase 1b
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still room to enroll in this experiment?
"According to the information on clinicaltrials.gov, this trial has been inactive since its last update in December 16th 2022. As such, it is not currently accepting new recruits; however there are 443 other studies that can be considered for participation at present."
Answered by AI
What objectives is this research endeavor attempting to fulfill?
"The central goal of this study, monitored over a period of 12 months, is to determine the recommended phase 2 dose (RP2D) for allogeneic arms and identify any patient or product characteristics which could improve manufacturing. Secondary objectives include assessing tolerability through treatment emergent adverse events and serious adverse events in addition to clinical laboratory tests such as liver function tests, renal function and complete blood counts; monitoring vital signs including heart rate, temperature and pulse oximetry; analyzing overall response rates based on CR or PR responses;and measuring time-to-progression from first dose until objective tumor progression."
Answered by AI
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