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CAR T-cell Therapy

Genetically Modified Gamma-Delta T Cells for Glioblastoma

Cleveland Clinic, Cleveland, OH
Autologous genetically modified gamma-delta T cells +1 morePhase 1 & 2RecruitingLed by Louis B Nabors, MDResearch Sponsored by In8bio Inc.

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.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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In Arms A and C, you must have recently been diagnosed with glioblastoma and have not received any treatment for it before.
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You are able to perform daily activities with at least 70% of your normal ability.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more
Secondary outcome measures
Assessment of safety
Assessment of tolerability
Definition of product characteristics
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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.

Find a Location

Who is running the clinical trial?

In8bio Inc.Lead Sponsor
2 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Glioblastoma
12 Patients Enrolled for Glioblastoma
Louis B Nabors, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
4 Previous Clinical Trials
85 Total Patients Enrolled
3 Trials studying Glioblastoma
76 Patients Enrolled for Glioblastoma

Media Library

Allogeneic genetically modified gamma-delta T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05664243 — Phase 1 & 2
Glioblastoma Research Study Groups: 1) Autologous: Phase 2 Arm A, 2) Allogeneic: Phase 1b, 3) Allogeneic: Phase 2 Arm B, 4) Allogeneic: Phase 2 Arm C
Glioblastoma Clinical Trial 2023: Allogeneic genetically modified gamma-delta T cells Highlights & Side Effects. Trial Name: NCT05664243 — Phase 1 & 2
Allogeneic genetically modified gamma-delta T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05664243 — Phase 1 & 2

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
Recent research and studies
clinicaltrials.govStudy
A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma
2023. "A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05664243.
All > Glioblastoma Cincinnati > Glioblastoma Multiforme
~80 spots leftby Dec 2025
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