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)
Cellectis S.A.
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).
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Relapsed or refractory (R/R) mature B-NHL per 2016 WHO criteria and positive for CD20 and/or CD22 * Subjects with NHL subtypes defined by WHO: * Dose-Finding Part: R/R mature B-NHL (except chronic lymphocytic leukemia/small lymphocytic leukemia \[CLL/SLL\], Richter's transformation from prior CLL/SLL, Burkitt's lymphoma, and Waldenstrom's macroglobulinemia) * Dose-Expansion Part: R/R LBCL, defined as: i. DLBCL; ii. High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements; iii. Tran…
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
Locations (10)
- The University of Chicago Medical Center (UCMC)Chicago, Illinois
- Harvard Medical School - Massachusetts General HospitalBoston, Massachusetts
- Rutgers Cancer Institute of New Jersey (CINJ) - New BrunswickNew Brunswick, New Jersey
- Sarah Cannon - St. David South Austin Medical CenterAustin, Texas
- Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-SudPierre-Bénite, Auvergne Rhone Alpe
- Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Saint-EloiMontpellier, Occitanie