Cellular Immunotherapy Clinical Trials for Leukemia and Lymphoma

Seattle Children’s doctors and researchers are leaders in developing and administering new therapies that stimulate the immune system (immunotherapies) to treat children, teens and young adults with relapsed or refractory leukemia and lymphoma. We offer state-of-the-art therapies and investigational clinical trials often not available at other hospitals.

Many of these promising immunotherapies are T-cell therapy, including some developed by Seattle Children’s Therapeutics. Read more about how T-cell immunotherapy works. We also develop and study other such as and .

What immunotherapy clinical trials are open for patients with leukemia and lymphoma?

These clinical trials authorized by the Food and Drug Administration (FDA) study new treatments for children and adults with or leukemia or lymphoma that have failed standard therapies. For information, call 206-987-2106 or send us an email at [email protected].

The study team at Seattle Children’s can explain the factors that determine if a patient can take part in a study (inclusion criteria) or cannot take part (exclusion criteria).

PLAT-08 (Pediatric Leukemia Adoptive Therapy-08) is a phase 1 clinical trial open to children and young adults up to age 28 with relapsed or refractory acute myeloid leukemia (AML). In PLAT-08, the T cells are reprogrammed to recognize and target the CD33 protein on the surface of the cancer cells. Read more about the PLAT-08 study at ClinicalTrials.gov.
FOLR1 is a phase 1 clinical trial of CAR T-cell therapy for children and young adults with relapsed or refractory AML. In this study, the T cells are reprogrammed to recognize and target the FOLR1 protein (folate receptor alpha) on the AML cell surface. See details of the FOLR1 study on ClinicalTrials.gov.
WU-CART-007 is a phase 2 study for children and young adults with relapsed or refractory T-cell acute lymphoblastic leukemia (ALL) or T-cell lymphoblastic lymphoma. The clinical trial uses healthy donor T cells genetically modified to target cancerous T cells that have the CD7 protein on their cell surface. Learn more about the WU-CART-007 study on ClinicalTrials.gov.
HA-1 TCR-T is a clinical trial for patients with acute leukemia that has come back (relapsed) or is resisting treatment (refractory) after a stem cell transplant from a healthy donor. This uses specific T cells from a donor to target a protein called HA-1 that is found in leukemic cells in some patients. Read the HA-1 TCR-T study protocol at ClinicalTrials.gov.
CAR-CURE study is assessing whether intensive monitoring after CD19 CAR T-cell therapy for patients with B-cell ALL helps to identify those most likely to benefit from a stem cell transplant. Patients will be monitored with next-generation sequencing (NGS) and tested for persistence of the CAR T cells. See details of this study on ClinicalTrials.gov.
Autolus study is a phase 2 clinical trial of CAR T-cell therapy for children and young adults with relapsed or refractory B-cell ALL or B-cell non-Hodgkin lymphoma (NHL). In this study, the T cells are reprogrammed to recognize and target the CD19 protein on the surface of the cancer cells. Read details of the Autolus study on ClinicalTrials.gov.
ADVANCE-01 is a phase 1 clinical trial of CAR T-cell therapy for children and young adults with relapsed or refractory AML. In this study, the T cells are reprogrammed to recognize and target the CLEC2A protein on the surface of the cancer cells.

What are the goals of these clinical trials?

We offer phase 1 and phase 2 trials. Phase 1 trials focus on finding out how much of a therapy to give, how to give it, how often to give it and what side effects occur. Phase 2 trials look at whether a therapy is safe and whether it works in people who have a certain disease.

Doctors hope that when these new therapies are fully tested, they will:

Work quickly, so treatment takes weeks, not years
Have milder side effects than other treatments, like chemotherapy

Are there immunotherapy clinical trials for other childhood diseases?

We offer many trials focused on using the immune system to better treat children, teens and young adults with diseases such as:

Solid tumors
Brain and central nervous system tumors
Systemic lupus erythematosus (REACT-01). Read about the first U.S. CAR T-cell clinical trial for children with lupus.

See many of Seattle Children’s open clinical trials:

On our Current Research Studies page.
Search by diagnosis for many clinical trials available through Seattle Children’s and our partners on ClinicalTrials.gov.