Skip to content
DataLookout
Start free
Menu

NCT05664243

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

StatusActive, Not Recruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from In8bio Inc.

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 14 versions: 14 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 2025 to Dec 2026 Show 4 more changesShow less
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Site details revised at 1 of 5 sites
    • Publications: details revised at 1 of 1 entry
  2. Study arms: 4 to 3v13
  3. Enrollment target: 120 to 4
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 8 to 5
    v12
  4. Study sites: 7 to 8v11
  5. Site details revised at 1 of 7 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 6 to 7v9
  2. Site details revised at 1 of 6 sitesv8
  3. Site details revised at 1 of 6 sitesv7
  4. Site contacts updated at 3 of 6 sitesv6
  5. Study sites: 4 to 6v5
  6. Study sites: 2 to 4
    • Start date changed from estimate of Sep 2023 to Sep 8, 2023
    v4
  7. Site contacts updated at 1 of 2 sitesv3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2023 to Sep 2023
    • Study sites: 1 to 2
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Autologous Phase 2, Arm A in newly diagnosed glioblastoma: 12-month overall survival (OS) rate
Timeframe: 12 Months
Allogeneic Phase 1b, establishes the recommended phase 2 dose (RP2D) for phase 2 allogeneic arms and subject or product characteristics that will optimize manufacturing
Timeframe: 28 days
Allogeneic Phase 2, Arm B confirmed recurrent glioblastoma, 9-month overall survival (OS)
Timeframe: 9 Months
Allogeneic Phase 2, Arm C newly diagnosed glioblastoma, 12-month overall survival (OS) rate
Timeframe: 12 Months

Secondary (6)

Assessment of safety
Assessment of tolerability
Overall response rate (ORR)
Time to progression (TTP)
Progression free survival (PFS)
Show 1 moreShow less
Definition of product characteristics

Arms and interventions

1) Autologous Newly Diagnosed Disease: Phase 2 Arm AExperimental

Arm A subjects with newly diagnosed disease will receive autologously derived, genetically modified gamma-delta T cells administered with maintenance temozolomide.

2) Allogeneic Relapsed Disease: Phase 1b and Phase 2Experimental

Phase 1b subjects with relapsed disease will have allogeneic derived, genetically modified gamma-delta T cells administered with temozolomide

3) Allogeneic Newly Diagnosed Disease: Phase 2 Arm CExperimental

Arm C subjects with newly diagnosed disease will receive allogeneic derived, genetically modified gamma-delta T cells administered with maintenance temozolomide.

Biologicals: Autologous genetically modified gamma-delta T cells, Allogeneic genetically modified gamma-delta T cells

Sites

5 sites in 1 country