What side effects are associated with this type of intervention?

The most common treatments for neuroblastoma, particularly those involving chimeric antigen receptor (CAR) T cells targeting GD2, can cause significant side effects. These include cytokine release syndrome (CRS) with symptoms like fever, nausea, headache, rash, rapid heartbeat, low blood pressure, and difficulty breathing. Neurological toxicities such as confusion, seizures, and encephalopathy are also frequent. Additionally, prolonged low blood cell counts and increased risk of infections due to immune suppression are notable side effects. These potential adverse effects necessitate careful patient monitoring and management.

What prior FDA approvals exist?

The FDA has approved several treatments for neuroblastoma, but specific approvals for genetically modified T cells targeting GD2 are limited. One notable approval is dinutuximab, an anti-GD2 monoclonal antibody used in combination with other therapies for high-risk neuroblastoma. While there are ongoing studies and trials for CAR T-cell therapies targeting GD2, such as the GD2-C7R T cells, these have not yet received FDA approval. The field of immunotherapy for neuroblastoma is evolving, with promising research in genetically modified T cells and other targeted therapies.

What other types of research exist?

Promising novel alternatives to GD2-C7R T cells for Neuroblastoma patients include: 1) CAR-T cell therapies targeting other antigens such as B7-H3 or L1-CAM, which are also expressed on neuroblastoma cells. 2) Antibody-drug conjugates (ADCs) that deliver cytotoxic agents directly to cancer cells expressing specific antigens. 3) Immune checkpoint inhibitors, which can enhance the body's immune response against cancer cells. 4) Oncolytic virus therapy, which uses genetically modified viruses to selectively infect and kill cancer cells while stimulating an anti-tumor immune response. 5) Combination therapies that integrate multiple modalities, such as combining CAR-T cells with checkpoint inhibitors or targeted therapies, to improve efficacy and overcome resistance.

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CAR T-cell Therapy

GD2-targeted CAR T-Cells for Neuroblastoma

Phase 1

Waitlist Available

Led By Bilal Omer, 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

Serum creatinine less than 3 times upper limit of normal. Creatinine clearance is needed for patients with creatinine greater than 1.5 times upper limit of normal

Recurrent disease following completion of aggressive multi-drug frontline therapy.

Must not have

Active autoimmune disease (requiring immunosuppressive treatment in the past 6 months)

Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 to 8 weeks post t cell infusion

Awards & highlights

Summary

This trial is for patients with certain cancers that have returned or didn't respond to treatment. It uses the patient's own T cells, modified to better fight cancer and survive longer. The goal is to find the safest dose and see how well these modified cells work against cancer. This approach has changed how doctors treat certain types of cancer by using modified T cells to find and destroy cancer cells.

Who is the study for?

This trial is for people aged 1-75 with certain types of cancer (like neuroblastoma, sarcoma, uveal melanoma, breast cancer) that have a substance called GD2 on their cells. The cancers should be resistant to standard treatments or have come back after treatment. Participants need to be relatively healthy otherwise, with a life expectancy of at least 12 weeks and stable organ function.

What is being tested?

The trial tests genetically modified T cells designed to last longer and fight cancer more effectively. These T cells are engineered to recognize and attack GD2 positive cancer cells. Before the T cell infusion, patients may receive chemotherapy to help these special immune cells work better.

What are the potential side effects?

Potential side effects include reactions related to gene therapy or immune responses such as fever, fatigue, allergic reactions to mouse proteins in the treatment (if not desensitized), autoimmune symptoms if predisposed, or complications from weakened immunity.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function tests are within the required range.

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My cancer has returned after intensive initial treatment.

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My cancer has returned after intensive initial treatment.

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My cancer did not respond well to initial strong chemotherapy.

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My osteosarcoma has not responded to standard treatments.

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My eye melanoma has spread, is GD2 positive, and got worse after treatment.

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My breast cancer is worsening despite 2+ treatments and is GD2 positive.

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My cancer is not responding to standard treatments and tests positive for GD2.

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I am able to care for myself but cannot do normal activities or work.

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I am between 2 and 74 years old.

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My neuroblastoma has come back or hasn't gone away.

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My T-cells are engineered to target my cancer effectively.

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My cancer has worsened despite strong initial treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an autoimmune disease and have been on immunosuppressants in the last 6 months.

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I have a primary brain tumor or brain metastases.

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I haven't had any experimental immune treatments or vaccines for cancer in the last 6 weeks.

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My tumor might be blocking my airways.

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I am not taking high doses of steroids or drugs like tacrolimus or cyclosporine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 to 8 weeks post t cell infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 to 8 weeks post t cell infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 to 8 weeks post t cell infusion for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Determine maximum tolerated dose (MTD) of C7R-GD2.CART Cells

Secondary study objectives

Determine Anti-tumor Responses

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: Standard risk group of all other patientsExperimental Treatment1 Intervention

Patients will be treated at 2 dose levels without lymphodepletion chemotherapy. Three patients will be evaluated and if safety is confirmed patients will be treated at the next dose level with C7R.GD2.CART cell infusion without lymphodepletion chemotherapy. The protocol is divided into two arms, a high-risk group of patients with lung metastases (Arm B) and a standard risk group of all other patients (Arm A). The standard risk Arm A includes osteosarcoma patients without pulmonary disease. Each arm will undergo separate dose escalation.

Group II: Arm A: High-risk group of patients with lung metastasesExperimental Treatment1 Intervention

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Neuroblastoma include chemotherapy, radiation therapy, surgery, and immunotherapy. Immunotherapy, particularly using genetically modified T cells like GD2-C7R T cells, is a promising approach. These T cells are engineered to express a chimeric antigen receptor (CAR) that specifically targets the GD2 antigen found on Neuroblastoma cells. Additionally, the inclusion of the C7R gene provides a constant supply of cytokines, enhancing the survival and efficacy of the T cells. This targeted approach is crucial for Neuroblastoma patients as it aims to improve treatment outcomes by directly attacking cancer cells while minimizing damage to healthy tissues.

Advances in Immunotherapies for Gliomas.Towards Immunotherapy for Pediatric Brain Tumors.

Find a Location

Who is running the clinical trial?

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,729 Total Patients Enrolled

6 Trials studying Rhabdomyosarcoma

137 Patients Enrolled for Rhabdomyosarcoma

Baylor College of MedicineLead Sponsor

1,018 Previous Clinical Trials

6,031,335 Total Patients Enrolled

6 Trials studying Rhabdomyosarcoma

137 Patients Enrolled for Rhabdomyosarcoma

Cancer Prevention Research Institute of TexasOTHER

52 Previous Clinical Trials

98,866 Total Patients Enrolled

Media Library

C7R-GD2.CART cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03635632 — Phase 1

Rhabdomyosarcoma Research Study Groups: Arm A: High-risk group of patients with lung metastases, Arm B: Standard risk group of all other patients

Rhabdomyosarcoma Clinical Trial 2023: C7R-GD2.CART cells Highlights & Side Effects. Trial Name: NCT03635632 — Phase 1

C7R-GD2.CART cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03635632 — Phase 1

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