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INB-400

Phase 1

Glioblastoma | Monoclonal antibody | Oncology |IN8bio, Inc.|Trials Updated: May 1, 2025

INB-400 target and mechanism

ModalityMonoclonal antibody

Also known as Autologous genetically modified gamma-delta T cells

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment4

FDA Designations

ORPHAN_DRUG

INB-400 clinical trials

INB-400 · 1 trial · 1 indication

Phase 1 1
NCT05664243A 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 GlioblastomaGlioblastoma
ACTIVE NOT_RECRUITING4 Analytics
PHASE1ACTIVE NOT_RECRUITING
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
GlioblastomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Autologous Phase 2, Arm A in newly diagnosed glioblastoma: 12-month overall survival (OS) rate
12 Months

Date of first dose to date of death by any cause

Allogeneic Phase 1b, establishes the recommended phase 2 dose (RP2D) for phase 2 allogeneic arms and subject or product characteristics that will optimize manufacturing
28 days

\<30% dose limiting toxicity (DLT) observed with dose

Allogeneic Phase 2, Arm B confirmed recurrent glioblastoma, 9-month overall survival (OS)
9 Months

Date of first dose to date of death by any cause

Allogeneic Phase 2, Arm C newly diagnosed glioblastoma, 12-month overall survival (OS) rate
12 Months

Date of first dose to date of death by any cause

Secondary Endpoints

Assessment of safety
12 Months
Assessment of tolerability
12 Months
Overall response rate (ORR)
12 Months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1) Autologous Newly Diagnosed Disease: Phase 2 Arm AEXPERIMENTALArm 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 2EXPERIMENTALPhase 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 CEXPERIMENTALArm C subjects with newly diagnosed disease will receive allogeneic derived, genetically modified gamma-delta T cells administered with maintenance temozolomide.

Interventions

NameTypeDescription
Autologous genetically modified gamma-delta T cellsBIOLOGICALArm 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 cellsBIOLOGICALPhase 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
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Subjects with histologically or cytologically confirmed history of IDH-wild type glioblastoma * Phase 1b and Arm B of Phase 2: Subjects must have completed no more than one standard therapy for glioblastoma, have received no prior Avastin® therapy (unless solely used for ed...

Countries:United States
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Frequently asked questions about INB-400

What is INB-400?

INB-400 is an investigational cell therapy being developed by IN8bio, Inc. for glioblastoma, a type of brain cancer. It consists of autologous genetically modified gamma-delta T cells, meaning the cells are derived from the patient and engineered before being returned to the patient. It is in Phase 1 clinical development.

What is INB-400 used for in glioblastoma?

INB-400 is being studied for use in patients with recurrent or newly diagnosed glioblastoma. It is given in combination with maintenance temozolomide, a standard chemotherapy, as part of a Phase 1b/2 clinical trial. The trial is currently active but not recruiting.

Who makes INB-400?

INB-400 is developed by IN8bio, Inc., a biotechnology company. IN8bio trades on the Nasdaq under the ticker symbol INAB. The company is focused on developing gamma-delta T cell therapies for cancer.

What phase is INB-400 in?

INB-400 is in Phase 1 clinical development. It is being evaluated in a Phase 1b/2 trial for glioblastoma. The trial is active but not recruiting, and no completed trials have been reported. INB-400 has received orphan drug designation from the FDA.

What clinical trials is INB-400 in?

INB-400 is being studied in one clinical trial, NCT05664243, 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." The trial is active but not recruiting and has enrolled 4 participants in the United States.

Is INB-400 the same as autologous genetically modified gamma-delta T cells?

Yes, INB-400 is also known as autologous genetically modified gamma-delta T cells. This alternative name describes the composition of the therapy: it uses the patient's own gamma-delta T cells that have been genetically modified. The trial also includes an allogeneic arm, but INB-400 specifically refers to the autologous version.