Recruiting

Testing modified immune cells to treat hard-to-treat blood cancers

Plain-English translation of NCT04815356 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated July 2026 · How we translate trials

What is this trial?

This is the first trial testing anti-CD22 CAR T-cell therapy for hairy cell leukemia and hairy cell leukemia variant in patients whose cancer has stopped responding to other treatments. Doctors will take some of your immune cells, genetically modify them in a laboratory to recognize and attack your cancer cells, and then give them back to you. The trial will test different doses of this treatment to find the safest and most effective amount.

Some patients with hairy cell leukemia or its variant have cancers that no longer respond to standard chemotherapy, immunotherapy, or targeted drugs—including a drug called moxetumomab pasudotox-tdfk that was approved specifically for this disease. This medication represents a promising new option for patients who have run out of other treatment choices.

Do you qualify?

You likely qualify if…

you have been diagnosed with hairy cell leukemia or hairy cell leukemia variant confirmed by a biopsy
your cancer has progressed or stopped responding to at least three prior treatment approaches: chemotherapy with rituximab, moxetumomab pasudotox-tdfk, or BRAF-targeted therapy
your cancer cells show CD22 protein on more than 80% of the malignant cells (confirmed by lab testing)
you are at least 18 years old
your liver, kidney, and blood clotting function are adequate (measured by blood tests)
you have measurable disease, which could include minimal residual disease detected by laboratory tests

You likely don't qualify if…

you have active infection or uncontrolled infection at the time of enrollment
you have severe organ damage (liver, kidney, or heart function) that would prevent your body from tolerating the treatment
you have had an allogeneic stem cell transplant and are still within 100 days of transplant, or you still have graft-versus-host disease, or you are still taking immunosuppressive medications
you are pregnant or breastfeeding
you have untreated cancer in your central nervous system (brain or spinal cord), though some CNS involvement may be permitted

What participation looks like

If you join this trial, doctors will first collect some of your blood cells and send them to a laboratory where they will be genetically modified to recognize your cancer. While your cells are being prepared—which takes several weeks—you may receive other supportive care as needed. Once your modified cells are ready, you will receive them back as an infusion. You will then be closely monitored with frequent blood tests and visits to watch for side effects and to see how well the treatment is working. The trial will test different dose levels to determine the safest and most effective amount of the medication.

Testing modified immune cells to treat hard-to-treat blood cancers

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)