Rondecabtagene Autoleucel Vs. CD19 CAR T Cell Therapy in Large B-Cell Lymphoma

Purpose of Study

What is the Purpose of this Study?

The purpose of this study is to find new ways to treat lymphomas that have either come back after treatment or have stopped responding to treatment in patients who have aggressive B-cell non-Hodgkin lymphoma. The study involves an experimental treatment using the patient’s own immune cells (T cells) that have been genetically modified to help recognize and attack their cancer. Specifically, the study will evaluate a gene transfer product called rondecabtagene autoleucel (ronde-cel), which is known as a type of CAR T cell and targets 2 proteins on cancer cells, namely CD19 and CD20. Researchers will evaluate how well ronde-cel destroys cancer cells and determine whether ronde-cel destroys cancer cells the same as, or better than, other CAR T cell drugs that target only CD19 on cancer cells and are already approved by the U.S. Food and Drug Administration (FDA). Participants will be asked to undergo leukapheresis (a procedure to remove white blood cells from the blood), chemotherapy, and CAR T cell drug administration. They will be randomly assigned to receive either ronde-cel, a dual CD19/CD20 targeting CAR T, or an approved single CD19-targeting CAR T cell drug (axi-cel or liso-cel). Study procedures also include follow-up exams and blood collection.


Study Eligibility

Eligibility


  • 1. CAR T cell naïve and eligible to receive a CD19 CART-cell therapy
  • 2. Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)
  • * Diffuse large B-cell lymphoma (DLBCL)
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Study Sites

Where can I participate?



CS Cancer at Cedars-Sinai Medical Center : Emilie Douine-Barthelemy

More about this Clinical Trial

What is the full name of this clinical trial?

LYL314-102: A Phase 3 Randomized Controlled Trial of RONDECABTAGENE AUTOLEUCEL, An Autologous, Dual-Targeting CD19/CD20 CAR T-CELL Product Candidate, Versus Investigators Choice of CD19 CAR T-CELL Therapy in Patients With Relapsed or Refractory LARGE B-CELL Lymphoma in the Second-Line Setting PINACLE-H2H)

Study Details
Disease Type/Condition

Lymphoid Leukemia

Principal Investigator
1

Merchant, Akil

Co-Investigators

David Oveisi, Hannah Lee, Hitomi Hosoya, Joshua Sasine, Justin Darrah, Lawrence Liu, Noah Merin, Ronald Paquette

Age Group

Adult

Phase

III

IRB Number

STUDY00004535

ClinicalTrials.gov ID

NCT07188558

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?

Name

Emilie Douine-Barthelemy

Email

emilie.douine-barthelemy@cshs.org
Study Detail
Disease Type/Condition

Lymphoid Leukemia

Principal Investigator

Merchant, Akil

Age Group

Adult

Phase

III

IRB Number

LYL314-102

ClinicalTrials.gov ID

NCT07188558

Key Eligibility
ClinicalTrials.gov

Contact
Name

Emilie Douine-Barthelemy

Email
emilie.douine-barthelemy@cshs.org