Study Description
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).
Interventions
Ibrutinib
Rapcabtagene autoleucel single agent
Eligibility Criteria
Inclusion Criteria:
ECOG performance status 0-1
CLL or SLL diagnosis according to iwCLL criteria
CLL/SLL in SD or PR after at least 6 months of ibrutinib, either as second or subsequent line of therapy
DLBCL diagnosis by local histopathology
DLBCL relapsed or refractory after 2 or more lines of therapy, including autologous hematopoietic stem cell transplantation (HSCT)
Refractory or relapsed CD19-positive ALL
ALL with morphologic disease in the bone marrow
1L HR LBCL - Considered to be high-risk based on at least 1 of the following at diagnosis:
IPI score of 3, 4 or 5
MYC and BCL2 and/or BCL6 rearrangement (DH/THL)
Participants must have received 2 cycles of frontline therapy for LBCL with R-CHOP or Pola-R-CHP or DA-EPOCH-R. Participants with DH/TH lymphoma must have received DA-EPOCH-R.
Participants must have a positive PET per Lugano classification (Deauville PET score of 4 or 5 and an overall response of PR/SD) after 2 cycles of frontline CIT. Note: Patient's with Deauville PET score of 5 and overall response of PD, or with Deauville PET score of 1, 2, or 3 and overall response of CR, are not eligible for this trial.
Exclusion Criteria:
Prior CD19-directed therapy
Prior administration of a genetically engineered cellular product
Prior allogeneic HSCT
Richter's transformation
For 1L HR LBCL: Richter's transformation, Burkitt lymphoma, primary DLBCL of CNS, DLBCL associated with chronic inflammation, intravascular large B-cell lymphoma, ALK- positive large B-cell lymphoma, HHV8 positive LBCL, DLBCL leg type or EBV positive DLBCL, NOS.
Active CNS lymphoma
For 1L HR LBCL: Active CNS involvement by malignancy
Targeted small molecule or kinase inhibitor within 2 weeks from leukapheresis
Other protocol-defined inclusion/exclusion may apply.
Study Location
Novartis Investigative Site
Recruiting
Melbourne,Victoria,3000,Australia
Novartis Investigative Site
Recruiting
Melbourne,Victoria,3004,Australia
Novartis Investigative Site
Recruiting
Wien,A-1090,Austria
Novartis Investigative Site
Recruiting
Paris 10,75475,France
Novartis Investigative Site
Recruiting
Pierre Benite,69495,France
Novartis Investigative Site
Recruiting
Marseille,13273,France
Novartis Investigative Site
Recruiting
Koeln,50937,Germany
Novartis Investigative Site
Recruiting
Frankfurt,60590,Germany
Novartis Investigative Site
Recruiting
Milano,MI,20132,Italy
Novartis Investigative Site
Recruiting
Bergamo,BG,24128,Italy
Novartis Investigative Site
Recruiting
Bologna,BO,40138,Italy
Novartis Investigative Site
Recruiting
Fukuoka city,Fukuoka,812-8582,Japan
Novartis Investigative Site
Recruiting
Sapporo city,Hokkaido,060 8648,Japan
Novartis Investigative Site
Recruiting
Bunkyo ku,Tokyo,113-8677,Japan
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08035,Spain
Novartis Investigative Site
Recruiting
Barcelona,08041,Spain
Novartis Investigative Site
Recruiting
Madrid,28009,Spain
Novartis Investigative Site
Recruiting
Sevilla,Andalucia,41013,Spain
Novartis Investigative Site
Recruiting
Cordoba,Andalucia,14004,Spain
Novartis Investigative Site
Recruiting
Valencia,Comunidad Valenciana,46010,Spain
Novartis Investigative Site
Recruiting
Badalona,Catalunya,08916,Spain
H Lee Moffitt Cancer Center and Research Institute .
Recruiting
Tampa,Brian James (888-663-3488) email: brian[email protected] -- Julio Chavez,33612 - Florida,United States
University of Texas MD Anderson Cancer Center
Recruiting
Houston,Priscilla Cardenas (713-794-5783) email: pdcardenas@mdanderson.org -- Jason Westin,77030-4099 - Texas,United States
Sarah Cannon Research Institute Drug Ship - 4
Recruiting
Nashville,Lauren J Cary (615-329-7274) email: laur[email protected] -- Ian W. Flinn,37203 - Tennessee,United States
Mass Gen Hosp Cancer Center .
Recruiting
Boston,Kathryn D Cioffi (617-726-2000) email: [email protected] -- Matthew Frigault,02114 - Massachusetts,United States
St Davids South Austin Medical Ctr
Recruiting
Austin,Kristen Coulter (512-447-2211) email: kristen.coul[email protected] -- Aravind Ramakrishnan,78704 - Texas,United States
Medical College of Wisconsin Main Centre
Recruiting
Milwaukee,Jessica Neumann (414-805-4600) email: [email protected] -- Nirav Shah,53226 - Wisconsin,United States
Stanford University Medical Center
Recruiting
Stanford,Jhina Patro (650-725-0701) email: [email protected] -- Lori Muffly,94305-5826 - California,United States
Northside Hospital .
Recruiting
Atlanta,Adriane Strong (404-255-1930) email: adriane.strong@northside.com -- Scott D. Solomon,30342 - Georgia,United States
University of Chicago Medical Center Hematology and Oncology
Recruiting
Chicago,Elaine Hoekstra (773-834-8980) email: [email protected] -- Peter Riedell,60637 - Illinois,United States
Northwestern University Northwestern Memorial Hospital Trans
Recruiting
Chicago,Holly Roberta Krieg email: hollyroberta.krieg@northwestern.edu -- Shira Dinner,60611 - Illinois,United States
University of Kansas Cancer Center SC - CTL019C2201
Recruiting
Westwood,Claire McCann (913-588-6029) email: [email protected] -- Leyla Shune,66205 - Kansas,United States
University of Pennsylvania Clinical Perelman Center for Adv Med
Recruiting
Philadelphia,Rachael Purri (215-615-6721) email: [email protected] -- Noelle Frey,19104 - Pennsylvania,United States
Worldwide Contacts
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