Gene-Modified T Cell Therapy for Glioblastoma

Recruiting at7 trial locations

Overseen by Louis B Nabors, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: In8bio Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Louis B Nabors, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults with newly diagnosed or recurrent glioblastoma who haven't had more than one standard therapy and no prior Avastin, unless for edema. They must be in good physical condition (Karnofsky Performance ≥ 70%), agree to use two birth control methods if of childbearing potential, and have a suitable donor for the cell therapy. Exclusions include recent vaccinations or surgery, unresolved treatment side effects, other cancers within two years (unless low risk), allergies to certain drugs, uncontrolled illnesses that affect study compliance or interpretation.

Inclusion Criteria

I am willing to have a Rickham catheter placed and kept in.

I am 18 years old or older.

Subjects in Phase 1b and Arm B and Arm C must have a partially matched haploidentical or matched related donor

Exclusion Criteria

I haven't had encephalitis, multiple sclerosis, or a CNS infection in the year before my brain cancer diagnosis.

I received a vaccine or had surgery within the specified times before my leukapheresis collection.

I haven't had certain cancer treatments like immunotherapy or surgery in the weeks before joining the study.

Treatment Details

Interventions

• Allogeneic genetically modified gamma-delta T cells (CAR T-cell Therapy)
• Autologous genetically modified gamma-delta T cells (CAR T-cell Therapy)

Trial Overview The trial tests genetically modified gamma-delta T cells from either the patient (autologous) or a donor (allogeneic) combined with temozolomide chemotherapy in patients with glioblastoma. The goal is to see if this experimental cell therapy can improve survival by at least 25% compared to current treatments.

Participant Groups

Group I: 4) Allogeneic: Phase 2 Arm C Experimental Treatment 1 Intervention

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

Group II: 3) Allogeneic: Phase 2 Arm B Experimental Treatment 1 Intervention

Arm B subjects with relapsed disease will have allogeneic derived, genetically modified gamma-delta T cells administered with temozolomide

Group III: 2) Allogeneic: Phase 1b Experimental Treatment 1 Intervention

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

Group IV: 1) Autologous: Phase 2 Arm A Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

In8bio Inc.

Lead Sponsor

Trials

3

Recruited

60+