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Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL
Sponsor: Novartis Pharmaceuticals
Summary
This is a phase I/II study to evaluate the feasibility, safety and preliminary antitumor efficacy of rapcabtagene autoleucel (also known as YTB323). Rapcabtagene autoleucel will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (3L+ DLBCL), adult acute lymphoblastic leukemia (ALL) and 1st Line High Risk Large B-Cell Lymphoma (1L HR LBCL).
Official title: Phase I/II, Open Label, Multicenter Study of Rapcabtagene Autoleucel in Adult Patients With CLL/SLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
217
Start Date
2019-06-26
Completion Date
2027-06-30
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Rapcabtagene autoleucel single agent
Single infusion of rapcabtagene autoleucel
Ibrutinib
Tablets or capsules for oral daily use
Locations (38)
University of California LA
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Uni of Chi Medi Ctr Hema and Onco
Chicago, Illinois, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Mass Gen Hosp Cancer Center
Boston, Massachusetts, United States
University of Pennsylvania Clinical
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
St Davids South Austin Medical Ctr
Austin, Texas, United States
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Pierre-Bénite, France
Novartis Investigative Site
Rennes, France
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany
Novartis Investigative Site
Leipzig, Saxony, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Bergamo, BG, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Rozzano, MI, Italy
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan
Novartis Investigative Site
Fukuoka, Japan
Novartis Investigative Site
Badalona, Barcelona, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Córdoba, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Salamanca, Spain
Novartis Investigative Site
Seville, Spain
Novartis Investigative Site
Valencia, Spain