First-in-human, open-label, dose-finding and dose-expansion study of UCART20x22 administered intravenously in subjects with relapsed or refractory B-Cell Non-Hodgkin Lymphoma (B-NHL). The purpose of this study is to evaluate the safety and clinical activity of UCART20x22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Allogeneic engineered T-cells expressing anti-CD20 and anti-CD22 Chimeric Antigen Receptors given following a lymphodepletion regimen
A monoclonal antibody that recognizes a CD52 antigen
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
RECRUITINGHarvard Medical School - Massachusetts General Hospital
Boston, Massachusetts, United States
Dose finding and expansion parts: Incidence of adverse events/serious adverse events/dose limiting toxicity [Safety and Tolerability]
Incidence, nature and severity of adverse events and serious adverse events in relation to UCART20x22 and/or lymphodepletion
Time frame: From study entry through month 12
Dose finding part: Occurrence of Dose Limiting Toxicities (DLTs)
Time frame: Up to Day 28 post UCART20x22 infusion
Investigator assessed overall response rate (ORR) according to Lugano Response Criteria for Malignant Lymphoma
Time frame: At Day 28, Day 84, Month 6, Month 9, Month 12
Duration of Response
Time frame: From achievement of the initial response to disease relapse/progression or death from any cause, assessed up to Month 12
Progression-free survival (PFS)
Time frame: From the first day of any study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 12
Overall survival
Time frame: From initiation of any study treatment to death from any cause, assessed up to Year 15
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Rutgers Cancer Institute of New Jersey (CINJ) - New Brunswick
New Brunswick, New Jersey, United States
RECRUITINGSarah Cannon - St. David South Austin Medical Center
Austin, Texas, United States
RECRUITINGHospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre-Bénite, Auvergne Rhone Alpe, France
RECRUITINGCentre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Saint-Eloi
Montpellier, Occitanie, France
RECRUITINGCentre Hospitalier Universitaire de Nantes (CHU de Nantes)-Hotel-Dieu
Nantes, France
RECRUITINGAssistance Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis - Centre Integre en Cancerologie
Paris, Île-de-France Region, France
RECRUITINGUniversidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
Pamplona, Navarre, Spain
RECRUITINGHospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
Seville, Spain
RECRUITING