LYL314-102

What is the Purpose of this Study?

This study is testing a new cancer treatment called ronde-cel. People will be randomly placed into one of two groups: one gets ronde-cel, and the other gets a different treatment chosen by their doctor. Ronde-cel targets two parts of cancer cells, while other treatments target just one. People must stay close to Duke Hospital for at least 3 weeks and come back for follow-up visits.

What is the Condition Being Studied?

Diffuse Large B Cell Lymphoma

Who Can Participate in the Study?

You may be able to join this study if you are 18 or older and have a type of blood cancer called DLBCL or a similar kind. Your cancer must have come back or not responded to treatment. You cannot join if you have active cancer in your brain.

Age Group
Adults

What is Involved?

This study is testing a new cancer treatment called ronde-cel. It compares ronde-cel to other approved treatments for a type of blood cancer called diffuse large B cell lymphoma that has come back or is hard to treat. Doctors want to see which treatment works better.

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
Headshot of Chenyu Lin
Assistant Professor of Medicine
Protocol Number
IRB: PRO00119098
NCT: NCT07188558
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL