University of Florida Health Shands Cancer Hospital 32608 Gainesville United StatesRekrutierend» Google-Maps Ansprechpartner: Erin Dean Phone: 352-273-7832 E-Mail: erin.dean@medicine.ufl.edu» Ansprechpartner anzeigenWinship Cancer Institute of Emory University 30322 Atlanta United StatesRekrutierend» Google-Maps Ansprechpartner: Edmund Waller Phone: 404-727-4995 E-Mail: ewaller@emory.edu» Ansprechpartner anzeigenUniversity of Illinois Hospital & Health Sciences System 60612 Chicago United StatesRekrutierend» Google-Maps Ansprechpartner: Carlos Galvez Phone: 312-996-8866 E-Mail: cgalve3@uic.edu» Ansprechpartner anzeigen
Indiana Blood & Marrow Transplantation 46237 Indianapolis United StatesRekrutierend» Google-Maps Ansprechpartner: Melanie Coleman Phone: 317-528-7298 E-Mail: melanie.coleman@franciscanalliance.org» Ansprechpartner anzeigenUniversity of Louisville James Graham Brown Cancer Center 40202 Louisville United StatesRekrutierend» Google-Maps Ansprechpartner: Hassaan Yasin, MD Phone: 502-562-3919 E-Mail: cancertrials@louisville.edu» Ansprechpartner anzeigenAstera Cancer Care - East Brunswick 08816 New Brunswick United StatesRekrutierend» Google-Maps Ansprechpartner: Edward Licitra Phone: 732-390-7750 E-Mail: Stephanie.Ortiz@asterahealthcare.org» Ansprechpartner anzeigenAtrium Health Wake Forest Baptist Medical Center 27157 Winston-Salem United StatesRekrutierend» Google-Maps Ansprechpartner: Rakhee Vaidya, MD Phone: 336-716-2774 E-Mail: ravaidya@wakehealth.edu» Ansprechpartner anzeigenUniversity of Cincinnati Health Barett Cancer Center 45219 Cincinnati United StatesRekrutierend» Google-Maps Ansprechpartner: Tahir Latif Phone: 513-584-2118 E-Mail: latiftr@ucmail.uc.edu» Ansprechpartner anzeigenPrisma Health Cancer Institute-Eastside 29615 Greenville United StatesRekrutierend» Google-Maps Ansprechpartner: Suzanne Fanning Phone: 864-522-2066 E-Mail: suzanne.fanning@prismahealth.org» Ansprechpartner anzeigenSalzburg Cancer Research Institute 5020 Salzburg AustriaRekrutierend» Google-Maps Ansprechpartner: Richard Greil Phone: 4366244822879 E-Mail: r.greil@salk.at» Ansprechpartner anzeigenUniversitair Ziekenhuis Brussel 1090 Brussel BelgiumRekrutierend» Google-Maps Ansprechpartner: Ann De Becker Phone: 3224776211 E-Mail: ann.debecker@uzbrussel.be» Ansprechpartner anzeigen
1. To assess the clinical efficacy of ALLO-647 (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by PFS and assessed by IRC in subjects with R/R (Relapsed / Refractory) LBCL (Large B Cell Lymphoma) (Time Frame - Up to 60 months)
Secondary outcome:
1. To assess the clinical efficacy of ALLO-647 as measured by Overall Response Rate (ORR) and assessed by IRC between treatment arms (Time Frame - Up to 60 months)
2. To assess clinical efficacy of ALLO-647 with FC (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by Event-Free Survival (EFS) and assessed by IRC in subjects with R/R LBCL (Time Frame - Up to 60 months)
3. To characterize the efficacy of ALLO-647 as measured by Duration of Response (DOR) and assessed by IRC between treatment arms (Time Frame - Up to 60 months)
4. To characterize the efficacy of ALLO-647 as measured by Progression Free Survival (PFS) and assessed by IRC between treatment arms (Time Frame - Up to 60 months)
5. To characterize the efficacy of ALLO-647 as measured by response rate per investigator review (Time Frame - Up to 60 months)
6. To characterize the efficacy of ALLO-647 as measured by DOR and assessed by investigator assessments between treatment arms (Time Frame - Up to 60 months)
7. To characterize the efficacy of ALLO-647 as measured by Overall Survival (OS) (Time Frame - Up to 60 months)
8. To characterize lymphodepletion with and without ALLO-647 as measured by absolute lymphocyte count/microliter; T cell counts/microliter; B cell counts/microliter, NK cell counts/microliter (Time Frame - Up to 9 months)
9. To characterize the serum concentration of ALLO-647 as measured by microgram per microliter (Time Frame - Up to 10 days)
10. To characterize blood concentration of ALLO-501A when administered with lymphodepletion with and without ALLO-647 as measured by vector copy number (Time Frame - Up to 9 months)
11. To characterize the effects of ALLO-647 on host T cell concentrations as measured by T cell counts cells/microliter (Time Frame - Up to 9 months)
12. To evaluate the rate of anti-drug antibodies against ALLO-647 and ALLO-501A (Time Frame - Up to 9 months)
13. To evaluate the incidence of treatment-emergent adverse events of ALLO-647 by comparing ALLO-647, fludarabine, and cyclophosphamide (FCA) lymphodepletion with fludarabine and cyclophosphamide (FC) lymphodepletion (Time Frame - Up to 60 months)
14. To evaluate the incidence of treatment-emergent adverse events of ALLO-501A following lymphodepletion (Time Frame - Up to 60 months)
