Lyell Immunopharma,LYL314-102, Ph3,rand,Rondecabtagene vs Inv choi, CarT-cell,Lg B-cell lymphoma

What is the Purpose of this Study?

Primary Objectives: The primary endpoint of the study is to compare the efficacy of ronde-cel, an investigational CD19/CD20 CAR T-cell therapy, to the CD19 CAR T-cell therapies (axi-cel or liso-cel) based on EFS, defined as the time from randomization to death from any cause, disease progression, failure to achieve a response (PR or CR) by the Day 84 visit after CAR T-cell therapy administration, or start of new anti-lymphoma therapy without documented progression, whichever comes first. Response and disease progression on PET/computed tomography (CT) imaging per Lugano Criteria 2014 will be assessed by a blinded Independent Review Committee (IRC) for all patients. Key Secondary Objectives: The key secondary objectives of the study are to compare the efficacy of ronde-cel to CD19 CAR T-cell therapies (axi-cel and liso-cel) based on the ORR, CRR, PFS, and overall survival.


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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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

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