GD2-targeted CAR T-Cells for Neuroblastoma

Palo Alto (17 mi)

Overseen byBilal Omer, MD

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Baylor College of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

My kidney function tests are within the required range.

My cancer has returned after intensive initial treatment.

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.

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.

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.

Exclusion Criteria

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

I have a primary brain tumor or brain metastases.

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

My tumor might be blocking my airways.

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

Treatment Details

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.

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