LYL314-102 - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Diffuse Large B Cell Lymphoma

Who Can Participate in the Study?

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 Group
Adults

What is Involved?

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.

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, MD
Hematologic Oncologist
Protocol Number
IRB: PRO00119098
NCT: NCT07188558
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
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