Testing a new medication to reduce side effects from CAR T-cell therapy

Plain-English translation of NCT05905328 on ClinicalTrials.gov ↗ · Source last updated April 2026 · 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 medication called CTO1681 to help protect patients from serious side effects that can happen during CAR T-cell therapy for lymphoma. Specifically, researchers want to see if taking this medication before and during CAR T-cell treatment can prevent or reduce cytokine release syndrome—a dangerous condition where the immune system overreacts and causes severe inflammation.

CAR T-cell therapy is a powerful cancer treatment, but it can trigger severe side effects that put patients in the hospital. This medication is being studied to see if it can shield patients from these harmful reactions, making CAR T-cell therapy safer and more tolerable.

Do you qualify?

You likely qualify if…

you are at least 18 years old
you have been diagnosed with relapsed or refractory large B-cell lymphoma and have already had at least one prior treatment
you are scheduled to receive CAR T-cell therapy and have already completed leukapheresis (a blood collection procedure)
your heart, kidney, and liver function are adequate, as measured by specific blood tests and scans
you are in good enough health to tolerate CAR T-cell therapy (Eastern Cooperative Oncology Group performance status 0 to 1)

You likely don't qualify if…

you have received chemotherapy within the past 14 days
you have severe heart problems, including recent heart attack or stroke within the past 6 months, or heart failure
you have serious swallowing problems or absorption issues that cannot be controlled with medication
you have abnormal heart rhythms or significant electrolyte imbalances that are not corrected
you have a history of blood clots or require blood-thinning medications

What participation looks like

You will start taking the study medication three times daily for 15 days, beginning just before your CAR T-cell therapy. During this time and for 43 days after, you will have regular clinic visits for blood draws, urine tests, heart monitoring, and scans to check your safety and how well the treatment is working. You'll then continue to be monitored for up to 6 months to track both safety and your cancer response.

AI-generated summary from trial data · Jun 24, 2026 · Not medical advice

Trial locations(6 sites)

United States

University of California, Irvine - Chao Family Comprehensive Cancer Center, Orange, California

Georgia Cancer Center at Augusta University, Augusta, Georgia

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Duke Cancer Institute, Durham, North Carolina

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania