Testing engineered immune cells to fight aggressive blood cancers

Plain-English translation of NCT06213636 on ClinicalTrials.gov ↗ · Source last updated August 2025 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This trial is testing a new type of cancer treatment called CD19/CD22-targeted CAR-T cell therapy for people with aggressive blood cancers like leukemia and lymphoma that have come back or stopped responding to other treatments. Doctors take your own immune cells (T cells), genetically engineer them in the laboratory to recognize and attack cancer cells, and then infuse them back into your body. The goal is to see whether this personalized treatment is safe and effective for cancers that have proven difficult to treat.

Many patients with advanced blood cancers run out of effective treatment options when their disease comes back or stops responding to standard chemotherapy and other therapies. This medication represents a newer approach designed to harness your own immune system's power to target and destroy cancer cells that conventional treatments have failed to control.

Do you qualify?

You likely qualify if…

you have been diagnosed with acute lymphoblastic leukemia (ALL), lymphoma, or certain other blood cancers that have either come back after treatment or stopped responding to chemotherapy
your cancer is considered resistant or refractory, meaning it either did not shrink with previous treatment or has returned after you initially improved
your cancer cells test positive for CD19 or CD22 markers (proteins on the surface of the cancer cells)
you have either declined stem cell transplant, are not eligible for it, or your disease came back after a previous transplant
you have measurable disease that doctors can track on scans or blood tests

You likely don't qualify if…

you are currently undergoing active treatment with other cancer therapies that cannot be paused
you have uncontrolled infections or serious organ dysfunction
you have received previous CAR-T cell therapy and still have high levels of those engineered cells circulating in your blood
you have active graft-versus-host disease if you have had a previous stem cell transplant from a donor

What participation looks like

You will first receive two chemotherapy medications (fludarabine and cyclophosphamide) given intravenously over a few days to prepare your body. Then on day 0, you will receive an intravenous infusion of your engineered CAR-T cells, which takes 10–20 minutes. If you respond well and tolerate the treatment without serious side effects, you may be eligible to receive up to three additional doses of the treatment. Throughout the trial, you will have regular clinic visits and blood tests to monitor how you respond and watch for any side effects.

Testing engineered immune cells to fight aggressive blood cancers

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)