Purpose of this Study
In this study, people will be placed into one of two groups by chance. One group will receive a new treatment called ronde cel. The other group will receive a CAR T cell treatment that is already approved and chosen by their cancer doctor. The new treatment is made to target two parts of the cancer cells, while current treatments target only one part. People in the study must be able to stay close to the hospital for at least three weeks and come back for follow up visits so doctors can check their health.
Who Can Participate?
Eligibility
People can join this study if they are 18 years old or older and have a type of blood cancer called diffuse large B cell lymphoma or a related lymphoma that has changed into a more serious form. The cancer must have come back or not responded after chemotherapy treatment. People cannot join if they have untreated cancer in the brain.
Age Range
18-90
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a new type of cancer treatment called CAR T cell therapy. It looks at a new treatment called ronde cel and compares it to other CAR T cell treatments that are already approved. The study is for people who have a type of blood cancer called diffuse large B cell lymphoma that has come back or did not respond to earlier treatment. Researchers want to learn which treatment works better and how safe they are.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Lyell Immunopharma, Inc. / A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel, an Autologous, Dual-Targeting CD19/CD20 CAR T-Cell Therapy Product Candidate, Versus Investigator’s Choice of CD19 CAR T-Cell Therapy in Patients with Relapsed or Refractory Large B-Cell Lymphoma in the Second-Line Setting (PiNACLE-H2H)
Principal Investigator
Chenyu
Lin
Protocol Number
PRO00119098
NCT ID
NCT07188558
Phase
III
Enrollment Status
Open to Enrollment