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CAR T-cell Therapy

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

Phase 1
Waitlist Available
Led By Shoba Navai, 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
Recurrent or refractory HER2 positive primary central nervous system (CNS) tumor or HER2 positive tumor metastatic to the CNS. Patients in whom tumor resection (gross total or subtotal resection) is medically feasible can undergo surgery after procurement and prior to treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

iCAR Trial 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.Check my eligibility
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.See study design
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.

iCAR Trial 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.
Select...
My HER2 positive cancer has returned or didn’t respond to treatment and affects my brain.

iCAR Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with dose limiting toxicity after administration of autologous T cells expressing transgenic chimeric antigen receptors (CAR) targeting the HER2 molecule
Secondary outcome measures
Number of Patients with a tumor response

iCAR 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.

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteOTHER
270 Previous Clinical Trials
80,248 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
997 Previous Clinical Trials
6,002,009 Total Patients Enrolled
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,807 Total Patients Enrolled

Media Library

HER2-specific T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02442297 — Phase 1
Brain Tumor Research Study Groups: HER2-specific T cells - High Risk, HER2-specific T cells - Standard Risk
Brain Tumor Clinical Trial 2023: HER2-specific T cells Highlights & Side Effects. Trial Name: NCT02442297 — Phase 1
HER2-specific T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02442297 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the usage of HER2-specific T cells officially sanctioned by the FDA?

"The safety of HER2-specific T cells was assessed at 1 due to its Phase 1 status, indicating limited evidence supporting safety and efficacy."

Answered by AI

To what magnitude is the population involved in this research undertaking?

"Indeed. According to clinicaltrials.gov, this medical trial is presently recruiting and initially posted on February 1st 2016 with its most recent update being May 3rd 2022. It seeks 28 participants from 2 distinct locations."

Answered by AI

Is there an opportunity for participants to join this clinical trial?

"Indeed, the information hosted on clinicaltrials.gov suggests that this medical research is actively recruiting patients; it was posted on February 1st 2016 and has undergone revisions as recently as May 3rd 2022. The team conducting the trial requires 28 participants to be enrolled from 2 different sites."

Answered by AI
~1 spots leftby Mar 2025