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:<ul>
<li>Are diagnosed with DLBCL</li>
<li>Are planning to receive YESCARTA CAR T-cell therapy</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: caitlyn.campbell@duke.edu">caitlyn.campbell@duke.edu.</a>
<li>Are diagnosed with DLBCL</li>
<li>Are planning to receive YESCARTA CAR T-cell therapy</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: caitlyn.campbell@duke.edu">caitlyn.campbell@duke.edu.</a>
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:<ul>
<li>One group will get the study drug</li>
<li>The other group will get a placebo (inactive substance that has no drug in it)</li></ul>
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.
<li>One group will get the study drug</li>
<li>The other group will get a placebo (inactive substance that has no drug in it)</li></ul>
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