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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
No Placebo-Only Group
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 belowSelect...
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:Select...
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
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
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: 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
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.
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.
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
112 Previous Clinical Trials
2,761 Total Patients Enrolled
6 Trials studying Rhabdomyosarcoma
137 Patients Enrolled for Rhabdomyosarcoma
Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,416 Total Patients Enrolled
6 Trials studying Rhabdomyosarcoma
137 Patients Enrolled for Rhabdomyosarcoma
Cancer Prevention Research Institute of TexasOTHER
53 Previous Clinical Trials
98,950 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an allergic reaction to products containing murine protein, unless you have successfully undergone a desensitization process and re-challenge without another allergic reaction.I have an autoimmune disease and have been on immunosuppressants in the last 6 months.I have a primary brain tumor or brain metastases.You are expected to live for at least 12 weeks.Your liver function tests are within a certain range.My kidney function tests are within the required range.You need to have a certain level of white blood cells and platelets in your blood.Your oxygen levels are at least 90% when breathing normally in a room.My cancer has returned after intensive initial treatment.My tumor might be blocking my airways.I am not taking high doses of steroids or drugs like tacrolimus or cyclosporine.My cancer has returned after intensive initial treatment.I finished my last chemotherapy at least 4 weeks ago and have recovered from its immediate side effects.I haven't had any experimental immune treatments or vaccines for cancer in the last 6 weeks.My cancer did not respond well to initial strong chemotherapy.My osteosarcoma has not responded to standard treatments.My eye melanoma has spread, is GD2 positive, and got worse after treatment.I have heart or lung issues but meet specific health criteria.My breast cancer is worsening despite 2+ treatments and is GD2 positive.My cancer is not responding to standard treatments and tests positive for GD2.I am able to care for myself but cannot do normal activities or work.I am between 2 and 74 years old.I don't have antibodies against mouse proteins from previous treatments.My neuroblastoma has come back or hasn't gone away.My T-cells are engineered to target my cancer effectively.My cancer has worsened despite strong initial treatment.Your bilirubin levels are within a certain range.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: High-risk group of patients with lung metastases
- Group 2: Arm B: Standard risk group of all other patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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