NCT03666000

A Phase 1/1b, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate Safety and Clinical Activity of PBCAR0191 (Azercabtagene Zapreleucel or "Azer-cel") in Subjects With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

Study Summary

This is a Phase 1/1b, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of azer-cel, an allogeneic anti-CD19 CAR T, in adults with r/r B ALL, r/r B-cell NHL and CLL/SLL.

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Interventions

Azer-celBIOLOGICAL
Infusion of Allogeneic Anti-CD19 CAR T cells
FludarabineDRUG
Specified dose on specified days
CyclophosphamideDRUG
Specified dose on specified days
IL-2DRUG
Specified dose on specified days

Study Locations

FacilityCityStateCountry
Banner MD Anderson Cancer CenterGilbertArizonaUnited States
City of HopeDuarteCaliforniaUnited States
H. Lee Moffitt Cancer CenterTampaFloridaUnited States
Winship Cancer Institute Emory UniversityAtlantaGeorgiaUnited States
Northside Hospital Cancer InstituteAtlantaGeorgiaUnited States
University of MarylandBaltimoreMarylandUnited States
Tufts Medical CenterBostonMassachusettsUnited States
Dana-Farber Cancer InstituteBostonMassachusettsUnited States
Barbara Ann Karmanos Cancer Institute (Wayne State University)DetroitMichiganUnited States
University of MinnesotaMinneapolisMinnesotaUnited States
Weill Cornell Medical College - NY Presbyterian HospitalNew YorkNew YorkUnited States
Columbia University Irving Medical Center/New York Presbyterian HospitalNew YorkNew YorkUnited States
Duke UniversityDurhamNorth CarolinaUnited States
Ohio State UniversityColumbusOhioUnited States
Lifespan Cancer Institute at Rhode Island HospitalProvidenceRhode IslandUnited States
Baylor University Medical CenterDallasTexasUnited States
MD AndersonHoustonTexasUnited States
Medical College of WisconsinMilwaukeeWisconsinUnited States
Royal Prince Alfred HospitalCamperdownNew South WalesAustralia
Liverpool HospitalLiverpoolNew South WalesAustralia
Royal Adelaide HospitalAdelaideSouth AustraliaAustralia
St Vincent's Hospital MelbourneFitzroyVictoriaAustralia
Barwon Health - Andrew Love Cancer CentreGeelongVictoriaAustralia

Official Trial Information

View on ClinicalTrials.gov

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