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CAR T-cell Therapy

GINAKIT Cells for Neuroblastoma (GINAKIT2 Trial)

Phase 1

Recruiting

Led By Andras Heczey, 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

ANC ≥ 500/µl without the use G-CSF or GM-CSF for at least 48hrs.

Patients must have autologous transduced NKTs with greater than or equal to 20% expression of GD2-specific CAR.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

GINAKIT2 Trial Summary

This trial is testing a new way to fight cancer that combines two existing methods: antibodies and Natural Killer T cells. Antibodies are proteins that protect the body, and T cells are white blood cells that can kill other cells, including cancer cells. The new method being tested, called GD2-CAR, is designed to improve upon previous methods by specifically targeting neuroblastoma cells and by adding a gene segment to make the NKT cells last longer.

Who is the study for?

This trial is for children and young adults (1-21 years old) with high-risk neuroblastoma that has relapsed or not responded to treatment. They must weigh over 12kg, have a life expectancy of at least 12 weeks, and be able to undergo leukocyte apheresis. Their kidney function, blood counts, liver enzymes, and heart/lung health should meet specific criteria. Those who are pregnant or breastfeeding, have HIV infection or severe disease progression cannot participate.Check my eligibility

What is being tested?

The study tests GINAKIT cells in patients with neuroblastoma. These cells are the patient's own Natural Killer T (NKT) cells genetically modified to express GD2-CAR targeting cancer cells and IL-15 for improved survival. The goal is to find the highest safe dose that can effectively target the tumor.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune response such as fever or fatigue; damage to normal tissues expressing GD2; low blood cell counts leading to increased risk of infections; allergic reactions due to murine protein content.

GINAKIT2 Trial Eligibility Criteria

Inclusion Criteria

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

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My white blood cell count is healthy without needing medication for at least 2 days.

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My treatment involves NKT cells modified to target my cancer more effectively.

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I can undergo a procedure to remove white blood cells.

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I can care for myself but may need occasional help.

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I am between 1 and 21 years old.

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My neuroblastoma has come back or didn't respond to treatment.

GINAKIT2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose of autologous NKTs expressing a 2nd generation GD2-specific chimeric antigen receptor administered to patients with relapsed or refractory neuroblastoma.

Secondary outcome measures

Anti-tumor response of autologous GINAKIT cells in patients with relapsed/refractory neuroblastoma.

Other outcome measures

Immunologic response of autologous GINAKIT cells in patients with relapsed/refractory neuroblastoma.

GINAKIT2 Trial Design

1Treatment groups

Experimental Treatment

Group I: GINAKIT cellsExperimental Treatment1 Intervention

GINAKIT cells will be administer to patients with Neuroblastomas on Day 0.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,216 Total Patients Enrolled

13 Trials studying Neuroblastoma

269 Patients Enrolled for Neuroblastoma

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,781 Total Patients Enrolled

11 Trials studying Neuroblastoma

227 Patients Enrolled for Neuroblastoma

Andras Heczey, MDPrincipal Investigator - Baylor College of Medicine

Baylor College of Medicine

4 Previous Clinical Trials

69 Total Patients Enrolled

Media Library

GINAKIT Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03294954 — Phase 1

Neuroblastoma Research Study Groups: GINAKIT cells

Neuroblastoma Clinical Trial 2023: GINAKIT Cells Highlights & Side Effects. Trial Name: NCT03294954 — Phase 1

GINAKIT Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03294954 — Phase 1

Frequently Asked Questions

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

What therapeutic advantages does the GINAKIT Cell offer?

"GINAKIT Cells are generally used to combat multiple sclerosis, yet they may also provide assistance for individuals suffering from mixed-cell type lymphoma, leukemia, myelocytic cancer, acute malignancies, and retinoblastoma."

Answered by AI

Has there been any previous research conducted using GINAKIT Cells?

"At present, there are 889 clinical trials in progress that concern GINAKIT Cells. Of these, 161 have reached the third phase of testing and are being administered primarily in Philadelphia, Pennsylvania; however, 28443 sites across the country participate in relevant studies."

Answered by AI

Does the trial have an age limitation for participation?

"This research project is seeking participants aged between one year and twenty-one years."

Answered by AI

Has GINAKIT Cells obtained clearance from the Food and Drug Administration?

"Our assessment of GINAKIT Cells' safety is low, a 1 on our scale of 1-3 due to the limited evidence backing its efficacy and security in this early Phase 1 trial."

Answered by AI

Are there still opportunities to join this research endeavor?

"According to the clinicaltrials.gov website, this research project is actively recruiting participants. First posted on January 18th 2018, it was last modified on August 5th 2022."

Answered by AI

What is the number of volunteers participating in this trial?

"Affirmative. Clinicaltrials.gov verifies that this research is actively recruiting participants; the investigation, which was initially published on January 18th 2018, seeks 36 volunteers from a single centre."

Answered by AI

What type of patient is most suitable for this clinical trial?

"Potential participants in this trial must have been diagnosed with neuroblastoma and be between 1 year and 21 years of age. At the moment, there are 36 open slots to enrol in this medical research."

Answered by AI

Recent research and studies

in VivoJournal

NKT Cells Coexpressing a Gd2-specific Chimeric Antigen Receptor and IL15 Show Enhanced <i>in Vivo</i> Persistence and Antitumor Activity Against Neuroblastoma

Xu, Xin, Wei Huang, Andras Heczey, Daofeng Liu, Linjie Guo, Michael Wood, Jingling Jin, et al.. 2019. “NKT Cells Coexpressing a Gd2-specific Chimeric Antigen Receptor and IL15 Show Enhanced in Vivo Persistence and Antitumor Activity Against Neuroblastoma”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-19-0421.

Nature MedicineJournal

Anti-gd2 CAR-NKT Cells in Patients with Relapsed or Refractory Neuroblastoma: An Interim Analysis

Heczey, Andras, Amy N. Courtney, Antonino Montalbano, Simon Robinson, Ka Liu, Mingmei Li, Nisha Ghatwai, et al.. 2020. “Anti-gd2 CAR-NKT Cells in Patients with Relapsed or Refractory Neuroblastoma: An Interim Analysis”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-020-1074-2.

clinicaltrials.govStudy

GD2 Specific CAR and Interleukin-15 Expressing Autologous NKT Cells to Treat Children With Neuroblastoma

Andras Heczey 2018. "GD2 Specific CAR and Interleukin-15 Expressing Autologous NKT Cells to Treat Children With Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03294954.

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