Phase
Condition
Lymphoma, B-cell
Lymphoma
Treatment
CLLS52
UCART20x22
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 forCD20 and/or CD22
Subjects with NHL subtypes defined by WHO:
-Dose-Finding Part: R/R mature B-NHL (except chronic lymphocytic leukemia/smalllymphocytic 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 lymphomawith MYC and BCL2 and/or BCL6 rearrangements; iii. Transformed FL or transformedmarginal zone lymphoma (MZL); iv. Follicular lymphoma Grade 3B
R/R disease after at least 2 lines of prior treatment, which must have included:
-An Anti-CD20 MoAb and an anthracycline for DLBCL, high-grade B-cell lymphoma withMYC and BCL2 and/or BCL6 rearrangements, primary mediastinal large B-cell lymphoma (PMBCL), or transformed FL or MZL
-An alkylating agent in combination with an anti-CD20 MoAb for FL
-An anthracycline or bendamustine-containing chemotherapy regimen and a Bruton'styrosine kinase (BTK) inhibitor for mantle cell lymphoma (MCL)
-Autologous anti-CD19 CAR T-cell therapy, if approved and available for theindicated lymphoma subtype, unless the subject is unable or is ineligible to receiveapproved autologous anti-CD19 CAR T-cell therapy (e.g., fail leukapheresis ormanufacture, unable to wait for manufacture, CD19 negative disease, etc.)
Autologous hematopoietic stem cells must be available prior to the start of the LDregimen if the subject is considered high-risk for prolonged hematologic toxicity
Exclusion
Exclusion Criteria:
Prior use of an investigational product (except for cell or gene therapies andMoAbs) within 5 half-lives or within 14 days, whichever is shorter, prior to startof LD regimen
Previous approved therapy including chemotherapy, biologic (except MoAbs), ortargeted therapy for R/R B-NHL with 5 half-lives or within 14 days, whichever isshorter, prior to start of the LD regimen
Prior MoAb therapy (approved or investigational) within 30 days prior to start of LD
Prior systemic immunostimulatory agent within 3 half-lives prior to start of the LDregimen
Prior cell or gene therapy (approved or investigational) within 6 weeks of the startof LD
Prior cell or gene therapy (approved or investigational) targeting both CD20 andCD22
Autologous HSCT infusion within 6 weeks of the start of LD
Allogeneic HSCT within 3 months of the start of LD, or donor lymphocyte infusionwithin 6 weeks of the start of LD
Active acute or chronic graft versus host disease (GvHD). Subjects should be off allimmunosuppressive therapies for at least 6 weeks prior to start of LD
Radiotherapy within 8 weeks (except for palliative radiotherapy for specificon-target lesions) (prior to start of LD regimen)
Evidence of active central nervous system (CNS) lymphoma or previous CNS involvementof R/R B-NHL
Presence of an active and clinically relevant CNS disorder
Daily treatment with >20 mg prednisone or equivalent
Known active infection, or reactivation of a latent infection, whether bacterial orviral, fungal, mycobacterial, or other pathogens
History of hypersensitivity to alemtuzumab
History of neutralizing anti-drug antibody against alemtuzumab
Any known uncontrolled cardiovascular disease within 3 months of enrollment
Subjects requiring immunosuppressive treatment
Major surgery within 28 days prior to start of LD
Evidence of another uncontrolled malignancy within 2 years prior to Screening (except in situ nonmelanoma skin cell cancers and/or carcinoma in-situ of thecervix)
Study Design
Connect with a study center
Hôpital Lyon Sud
Pierre-Bénite, Auvergne Rhone Alpe 69310
FranceActive - Recruiting
Hôpital Saint Louis
Paris, Ile de France 75010
FranceActive - Recruiting
CHU de Nantes
Alexis-Ricordeau, Nantes 44000
FranceActive - Recruiting
CHU de Montpellier
Montpellier, Occitanie 34295
FranceActive - Recruiting
Clínica Universidad de Navarra
Pamplona, Navarra 31008
SpainActive - Recruiting
Hospital Universitario Virgen del Rocío
Sevilla, 41013
SpainActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Massachusetts General Hospital: Hematology Oncology
Boston, Massachusetts 02114
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Sarah Cannon - St. David South Austin Medical Center
Austin, Texas 78704
United StatesActive - Recruiting
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