NCT03960840

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

Study 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).

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Interventions

Rapcabtagene autoleucel single agentBIOLOGICAL
Single infusion of rapcabtagene autoleucel
IbrutinibDRUG
Tablets or capsules for oral daily use

Study Locations

FacilityCityStateCountry
University of California LALos AngelesCaliforniaUnited States
Stanford University Medical CenterStanfordCaliforniaUnited States
H Lee Moffitt Cancer Center and Research InstituteTampaFloridaUnited States
Uni of Chi Medi Ctr Hema and OncoChicagoIllinoisUnited States
University of Kansas Cancer CenterWestwoodKansasUnited States
Mass Gen Hosp Cancer CenterBostonMassachusettsUnited States
University of Pennsylvania ClinicalPhiladelphiaPennsylvaniaUnited States
Sarah Cannon Research InstituteNashvilleTennesseeUnited States
Sarah Cannon Research InstituteNashvilleTennesseeUnited States
St Davids South Austin Medical CtrAustinTexasUnited States
Uni Of TX MD Anderson Cancer CntrHoustonTexasUnited States
Medical College of WisconsinMilwaukeeWisconsinUnited States
Novartis Investigative SiteMelbourneVictoriaAustralia
Novartis Investigative SiteMelbourneVictoriaAustralia
Novartis Investigative SiteViennaAustria
Novartis Investigative SiteMarseilleFrance
Novartis Investigative SiteParisFrance
Novartis Investigative SitePierre-BéniteFrance
Novartis Investigative SiteRennesFrance
Novartis Investigative SiteFrankfurt am MainHesseGermany
Novartis Investigative SiteLeipzigSaxonyGermany
Novartis Investigative SiteEssenGermany
Novartis Investigative SiteBergamoBGItaly
Novartis Investigative SiteMilanMIItaly
Novartis Investigative SiteRozzanoMIItaly
Novartis Investigative SiteSapporoHokkaidoJapan
Novartis Investigative SiteBunkyo KuTokyoJapan
Novartis Investigative SiteFukuokaJapan
Novartis Investigative SiteBadalonaBarcelonaSpain
Novartis Investigative SiteL'Hospitalet de LlobregatBarcelonaSpain
Novartis Investigative SiteBarcelonaSpain
Novartis Investigative SiteBarcelonaSpain
Novartis Investigative SiteCórdobaSpain
Novartis Investigative SiteMadridSpain
Novartis Investigative SiteMadridSpain
Novartis Investigative SiteSalamancaSpain
Novartis Investigative SiteSevilleSpain
Novartis Investigative SiteValenciaSpain

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026