About this study
In recent years, there have been better outcomes for patients with newly diagnosed acute myeloid leukemia, acute lymphoblastic leukemia (B-ALL, T-ALL), lymphoma, and myelodysplastic syndrome. But patients whose disease has returned (relapsed or refractory) still have poor outcomes. Their treatment options are limited. They often respond poorly to chemotherapy and cannot get higher doses of chemotherapy. New treatments are needed.
The DIRECT70 clinical trial consists of these steps:
- We will collect some of your child’s T cells. These cells are a type of immune system cell that can fight infection and kill cancer in the body. We may also use T cells that were already collected and frozen.
- Once we have the T cells, we will change them in the lab so that they can recognize and kill cancer better. Cancer cells have a protein on their surface called CD-70. The patient’s new CAR-T cells (CD70+ CAR cells) will recognize this CD-70 protein “marker” on the cancer cells.
- Then, your child will get chemotherapy treatment with medicines (fludarabine and cyclophosphamide) to kill cancer cells.
- Next, we will give your child their own, new cancer-fighting CAR-T cells to kill any remaining cancer. These new CD70-CAR T cells may kill cancer cells without harming normal blood-forming cells.
Purpose of this clinical trial
The purpose of this study is to find the highest dose of CD70+ CAR cells that is safe to give to patients with CD70+ blood cancers. We will also study survival and side effects of patients who get chemotherapy and the CD70+ CAR cells.
Eligibility overview
Patients in the study must be 21 years old or younger and have:
- CD70+ acute myeloid leukemia, acute lymphoblastic leukemia (B-ALL, T-ALL), lymphoma, or myelodysplastic syndrome
- No graft vs. host disease from an earlier transplant
- An identified transplant donor
- Adequate organ function