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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.
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
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
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