About this study
This research study tests a new treatment for children and young adults with CD19-positive leukemia that has been difficult to treat or has come back after other therapies.
The treatment in this study is called CAR T-cell therapy. It is a type of immunotherapy. Scientists insert a CAR (chimeric antigen receptor) into T cells to allow them to better find and kill the cancer. The CAR T-cell therapy in this study uses memory T cells collected from a donor. The donor will be a parent or other close family member. Researchers will collect T cells from the donor and use them to manufacture a new product called memory CAR T cells. The use of memory CAR T cells is experimental, which means it is not approved by the U.S. Food and Drug Administration. However, similar CARs have been tested using patient T cells.
If you take part in this study, you will receive an infusion of CAR T cells that were made using memory T cells collected from your donor. Chemotherapy is often given for several days before the infusion. You will stay in the hospital for about a week.
You may or may not benefit from being in this study. But information gained from the study may help future patients with this type of leukemia.
Eligibility overview
Donor eligibility includes:
- At least 18 years old
- At least single haplotype matched family member
- Be eligible to be a donor (as defined in the study)
Recipient eligibility includes:
- 21 years old or younger
- Diagnosed with relapsed and/or refractory CD19-positive leukemia
- Cohort A only – Patient has relapsed and/or refractory CD19-positive leukemia and patient has previously received a hematopoietic cell transplant from the selected CAR-T donor
- Cohort B only: Not suitable for autologous CD19-CAR T-cell therapy (as defined in the study)
- Detectable CD19+ leukemia in the bone marrow
- Adequate organ study function (as defined in the study)