CAR T-Cell Therapy for Brain Cancer (iCAR Trial)

Phase 1

Waitlist Available

Led By Nabil M Ahmed, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky/Lansky score of greater than or equal to 60

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is for brain cancer patients specifically. It is testing a new way to fight cancer by combining two existing methods- antibodies and T cells. The purpose is to see if this new method is effective and has minimal side effects.

Who is the study for?

This trial is for patients with brain cancer that tests positive for a protein called HER2. Participants should have recurrent or resistant tumors, be able to undergo surgery if needed, and have a moderate ability to perform daily activities (Karnofsky/Lansky score ≥60). They must understand and sign the consent form.

What is being tested?

The study is testing T cells engineered with an antibody called anti-HER2 attached to them, known as HER2-CAR T cells. The goal is to determine the highest safe dose of these modified T cells, their side effects, and their effectiveness against brain tumors.

What are the potential side effects?

Potential side effects are not detailed in this summary but may include typical reactions related to immune therapies such as inflammation, fever-like symptoms, fatigue, allergic reactions or more serious complications due to immune system overactivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients with dose limiting toxicity after administration of autologous T cells expressing transgenic chimeric antigen receptors (CAR) targeting the HER2 molecule

Secondary study objectives

Number of Patients with a tumor response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: HER2-specific T cells - Standard RiskExperimental Treatment1 Intervention

All other patients not meeting the high risk description will be assigned to the Standard Risk arm. Three cell dosing schedules (1, 2, 3) consisting of combinations of three cell doses (A, B, C) will be evaluated.

Group II: HER2-specific T cells - High RiskExperimental Treatment1 Intervention

Subjects with HER2 staining of Grade 3 (51-100% of cells staining for HER2) and intensity scores of 3+ will be assigned to the High Risk arm. Three cell dosing schedules (1, 2, 3) consisting of combinations of three cell doses (A, B, C) will be evaluated.

0 / 1Eligibility criteria met