GD2-targeted CAR T-Cells for Neuroblastoma

Recruiting in Palo Alto (17 mi)

+1 other location

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

You are expected to live for at least 12 weeks.

Informed consent and assent (as applicable) obtained from parent/guardian and child

Your liver function tests are within a certain range.

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Exclusion 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.

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Treatment Details

Interventions

C7R-GD2.CART cells (CAR T-cell Therapy)

Trial OverviewThe 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.

Participant Groups

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