Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05664243
PHASE1/PHASE2

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

Sponsor: In8bio Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 1b / 2 Open-label Study to Investigate the Safety, Tolerance and Efficacy of Drug Resistant Immunotherapy (DRI) With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide (TMZ) in Subjects With Recurrent or Newly Diagnosed Glioblastoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4

Start Date

2023-09-08

Completion Date

2025-12

Last Updated

2025-05-01

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Autologous genetically modified gamma-delta T cells

Arm A: Cells will be administered on Day 1 of each of 6, 28-day cycles in combination with TMZ maintenance

BIOLOGICAL

Allogeneic genetically modified gamma-delta T cells

Phase 1b and Arm B: Cells will be administered on Day 1 of each of 6, 28-day cycles in combination with D1 of TMZ 150mg/m2 Arms C: Cells will be administered on Day 1 of each of 6, 28-day cycles in combination with TMZ maintenance

Locations (5)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Louisville Hospital/James Graham Brown Cancer Center

Louisville, Kentucky, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University Wexner Medical Center- James Cancer Center

Columbus, Ohio, United States