Reinfusing CAR T-cells with an immune-boosting drug for relapsed leukemia

Plain-English translation of NCT05310591 on ClinicalTrials.gov ↗ ·

What is this trial?

This study tests whether nivolumab, an immune-boosting medication, can help tisagenlecleucel (a type of leukemia-fighting cell therapy) work better when reinfused into children and young adults whose first infusion of this therapy didn't last long enough. The medication is designed to help the reinfused cells survive and fight the leukemia more effectively.

Sometimes CAR T-cell therapy stops working too quickly because the patient's immune system rejects the new cells or suppresses their growth. Early research suggests that this new medication can help prevent that rejection and allow the reinfused cells to do their job.

Do you qualify?

You likely qualify if…

you are between 1 and 25 years old with relapsed or refractory acute lymphoblastic leukemia
you have already been treated with tisagenlecleucel (CAR T-cell therapy) at least once
your leukemia is showing signs that the first CAR T-cell treatment stopped working within 6 months
you are healthy enough (with a life expectancy of at least 12 weeks and good organ function) to tolerate this treatment
you have a second batch of tisagenlecleucel cells available for reinfusion

You likely don't qualify if…

you have received other leukemia treatments (chemotherapy, other immunotherapy, or a stem cell transplant) after your first CAR T-cell infusion
you have an active autoimmune disease or a history of serious lung inflammation
you have received prior treatment with similar immune-boosting drugs (anti-PD1 or anti-PDL1 agents)
you have active or untreated hepatitis B or C, HIV, or any uncontrolled infection
you received a live vaccine within 45 days of starting the study

What participation looks like

You will receive the reinfused CAR T-cells followed by doses of the immune-boosting medication at different time points depending on which treatment group you are in. The study will closely monitor you for safety and effectiveness through blood tests, imaging, and clinic visits. Your participation will help researchers determine the safest and most effective way to combine these two treatments.

Reinfusing CAR T-cells with an immune-boosting drug for relapsed leukemia

What is this trial?

Do you qualify?

What participation looks like

Trial locations(13 sites)