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

Phase 1/2 Active not recruiting 4 enrolled In8bio Inc.

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2023-09-08
Primary completion: 2025-12
Completion: 2025-12

Publications

Zhao Y, Dong P, He W, Zhang J, Chen H. gammadelta T cells: Major advances in basic and clinical research in tumor immunotherapy. Chin Med J (Engl). 2024 Jan 5;137(1):21-33. doi: 10.1097/CM9.0000000000002781. Epub 2023 Aug 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Allogeneic genetically modified gamma-delta T cells	Unknown	—	Other
Subject	Autologous genetically modified gamma-delta T cells	Unknown	—	Other
Subject	Temozolomide	Small molecule	150 mg/m2	—

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

Summary

Timeline

Publications

Drugs

Indications