Sponsor study identifier
interventional
218
8 countries
37
Study Start
June 26, 2019
Actual (reported)Primary Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 24, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 24, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 21, 2019
Actual (reported)May 23, 2019
Actual (reported)June 26, 2019
Actual (reported)June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 24, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Phase 1: Dose recommendation: Incidence and nature of Dose Limiting Toxicities (Dose Escalation part only)
28 days
Phase 1: Safety: Incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs
24 months
Phase 1: Tolerability: Ibrutinib dose modifications in the CLL/SLL arm
24 months
Phase 1: Manufacture success: Number of patients infused with planned target dose
Dose escalation of rapcabtagene autoleucel in combination with ibrutinib
Dose escalation and expansion of rapcabtagene autoleucel single agent in 3L+ DLBCL
Dose escalation of rapcabtagene autoleucel single agent in adult ALL
Single infusion of rapcabtagene autoleucel
Tablets or capsules for oral daily use
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
TOCILIZUMAB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
View registry recordFormulated product
ETOPOSIDE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
POWDER FOR SOLUTION FOR INJECTION
View registry recordFormulated product
BENDAMUSTINE HYDROCHLORIDE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
View registry recordFormulated product
CYTARABINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry recordFormulated product
IBRUTINIB
The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
TOCILIZUMAB
Named ingredient: tocilizumab
View registry recordETOPOSIDE
Named ingredient: Etoposide
View registry recordBENDAMUSTINE HYDROCHLORIDE
Named ingredient: Bendamustine hydrochloride
View registry recordCYTARABINE
Named ingredient: Cytarabine
View registry recordIBRUTINIB
Named ingredient: ibrutinib
View registry recordFLUDARABINE PHOSPHATE
Named ingredient: fludarabine phosphate
View registry recordUniversity of California LA
Los Angeles, California, 90095, United States
Stanford University Medical Center
Stanford, California, 94305-5826, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Uni of Chi Medi Ctr Hema and Onco
Chicago, Illinois, 60637, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Mass Gen Hosp Cancer Center
Boston, Massachusetts, 02114, United States
University of Pennsylvania Clinical
Novartis Pharmaceuticals
Novartis Pharmaceuticals
218 participants (actual enrollment reported by the registry).
First Submitted
May 21, 2019
First Posted
May 23, 2019
Study Start
June 26, 2019
Actual (reported)24 months
Phase 2: Complete Response Rate (CRR) as assessed by local Investigator
CRR defined as best overall response (BOR) of CR after rapcabtagene autoleucel infusion as per Lugano criteria for 3L+ Diffuse Large B-Cell Lymphoma (DLBCL) and 1L High Risk Large B-Cell (HR LBCL)
24 months
Phase 1: Complete Response (CR)/Partial Response (CR) in CLL/SLL
24 months
Phase 1: BOR of CR/PR per Lugano criteria in 3L+ DLBCL
24 months
Phase 1: Duration of response (DOR) in CLL/SLL and 3L+ DLBCL
24 months
Phase 1: BOR in ALL as assessed by an Independent Review Committee (IRC)
month 3
Phase 1: DOR in ALL as assessed by an Independent Review Committee
24 months
Rapcabtagene autoleucel single agent in 1L HR LBCL
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
Formulated product
FLUDARABINE PHOSPHATE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
POWDER FOR SOLUTION FOR INJECTION/INFUSION
View registry recordTreatment programme
Rapcabtagene autoleucel single agent
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
Registry study type: Interventional
View registry recordContact the study team to confirm eligibility.
Philadelphia, Pennsylvania, 19104, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
St Davids South Austin Medical Ctr
Austin, Texas, 78704, United States
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, 77030, United States
Sarah Cannon Research Institute
San Antonio, Texas, 78229, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Novartis Investigative Site
Melbourne, Victoria, 3000, Australia
Novartis Investigative Site
Melbourne, Victoria, 3004, Australia
Novartis Investigative Site
Vienna, 1090, Austria
Novartis Investigative Site
Marseille, 13273, France
Novartis Investigative Site
Paris, 75475, France
Novartis Investigative Site
Pierre-Bénite, 69495, France
Novartis Investigative Site
Rennes, 35033, France
Novartis Investigative Site
Frankfurt am Main, Hesse, 60590, Germany
Novartis Investigative Site
Leipzig, Saxony, 04103, Germany
Novartis Investigative Site
Bergamo, BG, 24127, Italy
Novartis Investigative Site
Milan, MI, 20132, Italy
Novartis Investigative Site
Rozzano, MI, 20089, Italy
Novartis Investigative Site
Sapporo, Hokkaido, 0608648, Japan
Novartis Investigative Site
Bunkyo Ku, Tokyo, 1138677, Japan
Novartis Investigative Site
Fukuoka, 8128582, Japan
Novartis Investigative Site
Badalona, Barcelona, 08916, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Novartis Investigative Site
Barcelona, 08035, Spain
Novartis Investigative Site
Barcelona, 08041, Spain
Novartis Investigative Site
Córdoba, 14004, Spain
Novartis Investigative Site
Madrid, 28009, Spain
Novartis Investigative Site
Madrid, 28041, Spain
Novartis Investigative Site
Salamanca, 37007, Spain
Novartis Investigative Site
Seville, 41013, Spain
Novartis Investigative Site
Valencia, 46010, Spain
Primary Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 24, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
Study fields come from the primary record; confirmed relationships can use other sources. Selecting a record here changes its provenance and downloads, without replacing the displayed study fields.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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