Study of CTO1681 for Preventing and Treating Cytokine Release Syndrome in DLBCL Patients Receiving CAR T-Cell Therapy
This study is looking at a drug called CTO1681 to see if it can prevent or reduce a side effect called Cytokine Release Syndrome (CRS) in people with Diffuse Large B-cell Lymphoma (DLBCL). CRS is a common side effect of CAR T-cell therapy. If you are an adult (18 years or older) with DLBCL and are scheduled to receive specific CAR T-cell therapies (axicabtagene ciloleucel or lisocabtagene maraleucel), you might be able to join. The study will test different doses of CTO1681, which you would take three times a day for 15 days, starting just before your CAR T-cell therapy. The main goal is to see how safe CTO1681 is by tracking any side effects over 6 months.
- Study design
- This is an open-label study where participants will receive increasing doses of CTO1681. It plans to enroll 54 participants.
- What's involved
- You would take CTO1681 three times daily for 15 days. You will also provide blood and urine samples, have ECGs, scans, and other medical evaluations.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for safety and effectiveness for 43 days, with follow-up for safety and tumor response for up to 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of CTO1681 for the Prevention and Treatment of CRS in Patients Receiving CAR T-Cell Therapy
At a glance
Conditions
NCT05905328
Where you'd take part
This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Beth Israel Deaconess Medical Center
Boston, Massachusettsstudy coordinator listed
Recruiting
Duke Cancer Institute
Durham, North Carolinastudy coordinator listed
Recruiting
Fred Hutchinson Cancer Center
Seattle, Washingtonstudy coordinator listed
Recruiting
Georgia Cancer Center at Augusta University
Augusta, Georgiastudy coordinator listed
Recruiting
University of California, Irvine - Chao Family Comprehensive Cancer Center
Orange, Californiastudy coordinator listed
Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvaniastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Mike Howell, PhD · STUDY_CHAIR · CytoAgents, Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence of adverse events (AEs)6 months following start of treatment
AEs graded by CTCAE v5.0