Receive two infusions of a new immune cell treatment for aggressive leukemia

Back to Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia trials

What is this trial?

This trial is testing CD19 sequential CD22 in vivo CAR-T cell immunotherapy, a new way to fight hard-to-treat blood cancer. Instead of removing your immune cells and growing them in a lab, this treatment uses a special virus to reprogram your T cells and NK cells (infection-fighting cells) directly in your body to recognize and attack cancer cells. You would receive two infusions one week apart, and the treatment is designed to work without requiring intense chemotherapy beforehand.

Most patients with relapsed or refractory B-cell acute lymphoblastic leukemia have limited treatment options and poor outcomes. This medication aims to offer a simpler, faster approach to CAR-T cell therapy that doesn't require the complex and time-consuming process of removing cells, manufacturing them in a lab, and using harsh conditioning chemotherapy.

Do you qualify?

You likely qualify if…

you have been diagnosed with relapsed or hard-to-treat B-cell acute lymphoblastic leukemia confirmed by bone marrow or blood tests
your cancer cells express both CD19 and CD22 markers (shown on flow cytometry or immunophenotyping)
you are between 14 and 75 years old
you are in fairly good overall health with a life expectancy of at least 3 months
your heart, lungs, liver, and kidneys are working adequately based on blood tests and imaging

You likely don't qualify if…

you have severe heart disease, a very low ejection fraction, or a recent heart attack or cardiac stent
you have severe lung disease that limits your breathing
you have a severe active infection that cannot be controlled
you have active hepatitis B or C infection
you have severe autoimmune disease or a weakened immune system from birth

What participation looks like

You would come to the study center to receive your first infusion on Day 0, then return one week later on Day 7 for your second infusion—assuming your body has tolerated the first treatment well. Between the two infusions, the research team will check your blood counts, measure how many reprogrammed immune cells are present, monitor you for any side effects (especially a condition called cytokine release syndrome), and assess your overall health before deciding whether it's safe to proceed with the second dose. You'll likely have several follow-up visits after treatment to monitor how well the therapy is working and watch for any delayed side effects.

Testing a New Immune Cell Treatment for Hard-to-Treat Blood Cancer

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)