Open-label Dose-finding and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of UCART20x22 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (B-NHL)
Summary
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).
Arms & interventions
- BiologicalUCART20x22
Allogeneic engineered T-cells expressing anti-CD20 and anti-CD22 Chimeric Antigen Receptors given following a lymphodepletion regimen
- BiologicalCLLS52
A monoclonal antibody that recognizes a CD52 antigen
Outcome measures
Primary
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
Secondary
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
Eligibility criteria
Study locations (4)
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, 60637
Harvard Medical School - Massachusetts General Hospital
Boston, Massachusetts, 02114
Rutgers Cancer Institute of New Jersey (CINJ) - New Brunswick
New Brunswick, New Jersey, 08901
Sarah Cannon - St. David South Austin Medical Center
Austin, Texas, 78704