Actively Recruiting
Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma
Led by Cellectis S.A. · Updated on 2025-08-24
80
Participants Needed
10
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Relapsed or refractory mature B-Cell Non-Hodgkin Lymphoma positive for CD20 and/or CD22
- Dose-Finding Part: Relapsed/refractory mature B-NHL excluding CLL/SLL, Richter's transformation, Burkitt's lymphoma, and Waldenstrom's macroglobulinemia
- Dose-Expansion Part: Relapsed/refractory LBCL including DLBCL, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, transformed FL or marginal zone lymphoma, and follicular lymphoma Grade 3B
- Relapsed or refractory disease after at least 2 lines of prior treatment including specified chemotherapy agents depending on lymphoma subtype
- Autologous anti-CD19 CAR T-cell therapy if approved and available unless patient is unable or ineligible
- Autologous hematopoietic stem cells available if high-risk for prolonged hematologic toxicity
You will not qualify if you...
- Prior use of investigational products (except cell/gene therapies and monoclonal antibodies) within 5 half-lives or 14 days before lymphodepletion
- Previous approved therapy (chemotherapy, biologics except monoclonal antibodies, targeted therapy) within 5 half-lives or 14 days before lymphodepletion
- More than 4 lines of therapy for relapsed/refractory B-NHL before lymphodepletion
- Prior monoclonal antibody therapy within 30 days before lymphodepletion
- Prior systemic immunostimulatory agent within 3 half-lives before lymphodepletion
- Prior cell or gene therapy within 6 months before lymphodepletion
- Prior cell or gene therapy targeting both CD20 and CD22
- Autologous hematopoietic stem cell transplant within 6 weeks before lymphodepletion
- Allogeneic hematopoietic stem cell transplant within 3 months before lymphodepletion or donor lymphocyte infusion within 6 weeks
- Active acute or chronic graft versus host disease or on immunosuppressive therapy within 6 weeks
- Radiotherapy within 8 weeks before lymphodepletion except for palliative treatment
- Active or prior central nervous system lymphoma involvement
- Active and clinically relevant central nervous system disorder
- Daily prednisone or equivalent dose over 20 mg
- Active infections or reactivation of latent infections
- History of hypersensitivity or neutralizing antibodies against alemtuzumab
- Uncontrolled cardiovascular disease within 3 months
- Requirement for immunosuppressive treatment
- Major surgery within 28 days before lymphodepletion
- Another uncontrolled malignancy within 2 years except certain skin or cervical cancers
AI-Screening
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Trial Site Locations
Total: 10 locations
1
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States, 60637
Actively Recruiting
2
Harvard Medical School - Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Rutgers Cancer Institute of New Jersey (CINJ) - New Brunswick
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
4
Sarah Cannon - St. David South Austin Medical Center
Austin, Texas, United States, 78704
Actively Recruiting
5
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre-Bénite, Auvergne Rhone Alpe, France, 69310
Actively Recruiting
6
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Saint-Eloi
Montpellier, Occitanie, France, 34295
Actively Recruiting
7
Centre Hospitalier Universitaire de Nantes (CHU de Nantes)-Hotel-Dieu
Nantes, France, 44093
Actively Recruiting
8
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis - Centre Integre en Cancerologie
Paris, Île-de-France Region, France, 75010
Actively Recruiting
9
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
Pamplona, Navarre, Spain, 31008
Actively Recruiting
10
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
Seville, Spain, 41013
Actively Recruiting
Research Team
C
Cellectis Central Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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