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NCT05664243 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Glioblastoma, sponsored by In8bio.

Active
Registry status
Phase 1
Development phase
4
Enrollment target
5
Study locations

NCT05664243 is a Phase 1 study of Glioblastoma that is active but no longer recruiting, run by In8bio. The registered enrollment target is 4 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT05664243, a Phase 1 study of Glioblastoma, is active but no longer recruiting, sponsored by In8bio.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
4 participants
Enrollment target
5
Study locations

Study Summary

This multicenter, Phase 1b/2 study is being conducted to determine if the experimental cell therapy is safe, tolerable and can delay the return of cancer in patients with a newly diagnosed or recurrent glioblastoma multiforme (GBM) in combination with standard chemotherapy treatment temozolomide (TMZ). If there is a 25% or greater improvement in survival in this study then the therapy should be studied further.

Conditions Studied

Interventions

  • BIOLOGICAL Autologous genetically modified gamma-delta T cells
  • BIOLOGICAL Allogeneic genetically modified gamma-delta T cells

Study Locations (5)

Ohio

  • Cleveland Clinic - Cleveland
  • Ohio State University Wexner Medical Center- James Cancer Center - Columbus

Alabama

  • University of Alabama at Birmingham - Birmingham

Florida

  • Moffitt Cancer Center - Tampa

Kentucky

  • University of Louisville Hospital/James Graham Brown Cancer Center - Louisville

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2023-09-08
Est. Completion 2025-12
Phase Phase 1

Sponsor

In8bio

1 total trials

What the Registry Record Tells You About NCT05664243

The ClinicalTrials.gov registry entry for NCT05664243 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (96% lower). The listed sponsor is In8bio, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which Autologous genetically modified gamma-delta T cells is the first listed.

NCT05664243 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Ohio, Alabama, Florida.

Frequently Asked Questions

What is clinical trial NCT05664243 about?

NCT05664243 is a clinical study titled "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". This multicenter, Phase 1b/2 study is being conducted to determine if the experimental cell therapy is safe, tolerable and can delay the return of cancer in patients with a newly diagnosed or recurrent glioblastoma multiforme (GBM) in combination with standard chemotherapy treatment temozolomide (TM...

What is the current status of trial NCT05664243?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2023-09-08. Estimated completion is 2025-12.

What conditions does trial NCT05664243 study?

This clinical trial studies the following conditions: Glioblastoma.

What interventions are being tested in trial NCT05664243?

The interventions under investigation include: Autologous genetically modified gamma-delta T cells (BIOLOGICAL), Allogeneic genetically modified gamma-delta T cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT05664243?

This trial is sponsored by In8bio, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05664243 being conducted?

This trial has 5 study locations across Alabama, Florida, Kentucky, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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