CytoAgents:CTO1681 (Diffuse Large B-Cell Lymphoma)

Purpose of this Study

We are doing this study to find out if an experimental drug called CT01681 (the study drug) is a safe and effective option for people who get CAR T-cell therapy as a treatment for diffuse large B cell lymphoma (DLBCL). We want to know if the study drug has the potential to lower or prevent certain side effects of CAR T-cell therapy. The possible side effects of CAR T-cell therapy that the study drug is being developed to protect against are called cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. This study is enrolling people who will receive an available form of CAR T-cell therapy called YESCARTA.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with DLBCL
  • Are planning to receive YESCARTA CAR T-cell therapy
For more information about who can join this study, please contact the study team at caitlyn.campbell@duke.edu.

What is Involved?

Description

If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
  • One group will get the study drug
  • The other group will get a placebo (inactive substance that has no drug in it)
You will start taking the study drug the day before your YESCARTA infusion. You will continue to take the study drug for 2 weeks after your infusion (total of 15 days). The study drug is a pill that you take 3 times per day.

Study Details

Full Title

A Phase 1b/2a Study of CTO1681 for the Prevention and Treatment of Cytokine Release Syndrome in Patients with Diffuse Large B-cell Lymphoma Receiving CAR T-cell Therapy

Principal Investigator

Chenyu
Lin

Protocol Number

PRO00114755

NCT ID

NCT05905328

Phase

I/II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov