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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 to 8 weeks post t cell infusion
Awards & highlights

Study Summary

This trial is for patients with cancer that has come back or did not respond to treatment. The patients will have their own T cells removed and a new gene will be put into the cells that will help them recognize and kill cancer cells. The cells will be put back into the patient and it is hoped that they will kill the 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine maximum tolerated dose (MTD) of C7R-GD2.CART Cells
Secondary outcome measures
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
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.

Find a Location

Who is running the clinical trial?

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,723 Total Patients Enrolled
11 Trials studying Neuroblastoma
169 Patients Enrolled for Neuroblastoma
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,086 Total Patients Enrolled
13 Trials studying Neuroblastoma
211 Patients Enrolled for Neuroblastoma
Cancer Prevention Research Institute of TexasOTHER
50 Previous Clinical Trials
98,344 Total Patients Enrolled

Media Library

C7R-GD2.CART cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03635632 — Phase 1
Neuroblastoma Research Study Groups: Arm A: High-risk group of patients with lung metastases, Arm B: Standard risk group of all other patients
Neuroblastoma 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

Frequently Asked Questions

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

Is eligibility for this trial restricted to persons under the age of 35?

"This research is seeking out individuals between 1 and 74 years of age to participate."

Answered by AI

What maladies have C7R-GD2.CART cells been utilized to help manage?

"C7R-GD2.CART cells are an effective treatment for multiple sclerosis, as well as a range of other medical conditions including mixed cell type lymphoma, leukemia, myelocytic acute and retinoblastoma."

Answered by AI

What qualifications must a person possess to be eligible for this trial?

"To be eligible for this clinical trial, participants must have sarcoma and fall in the age range of 1 year to 74. Currently, 94 individuals are being sought after."

Answered by AI

Has the FDA ratified C7R-GD2.CART cells for therapeutic usage?

"Our team at Power evaluated the safety of C7R-GD2.CART cells and assigned them a score of 1 due to it being an early stage trial with limited evidence supporting efficacy or safety."

Answered by AI

Are there any vacancies for participants in this experiment?

"As seen on clinicaltrials.gov, this investigation is currently searching for participants. It was initially posted in April of 2019 and the details were most recently updated at the end of August 2022."

Answered by AI

How many participants are being granted access to this experiment?

"Affirmative. According to clinicaltrials.gov, this trial launched on April 23rd 2019 and was recently updated on August 30th 2022 is actively looking for 94 participants across 2 locations."

Answered by AI

Are there any antecedent research trials that have employed C7R-GD2.CART cells?

"Currently, 889 clinical trials are in progress and focusing on C7R-GD2.CART cells with 161 of those studies taking place at Phase 3. These trails primarily occur in Philadelphia, however there are over 28 thousand sites across the country running these tests."

Answered by AI

Who else is applying?

What site did they apply to?
Texas Children's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
C7R-GD2.CART Cells for Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Cancers (GAIL-N)
Bilal Omer 2019. "C7R-GD2.CART Cells for Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Cancers (GAIL-N)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03635632.
All > Breast Cancer Houston > Rhabdomyosarcoma
~2 spots leftby Jun 2024
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