Phase
Condition
Lymphoma
Lymphoma, B-cell
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 lymphoma with MYC and BCL2 and/or BCL6rearrangements; iii. Transformed FL or transformed marginal 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 the indicatedlymphoma subtype, unless the subject is unable or is ineligible to receive approvedautologous anti-CD19 CAR T-cell therapy (e.g., fail leukapheresis or manufacture,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
> 4 lines of therapy R/R B-NHL 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 months of thestart of 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
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre-Bénite, Auvergne Rhone Alpe 69310
FranceSite Not Available
Hôpital Lyon Sud
Pierre-Bénite, Auvergne Rhone Alpe 69310
FranceActive - Recruiting
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre-Bénite 2987314, Auvergne Rhone Alpe 69310
FranceActive - Recruiting
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis - Centre Integre en Cancerologie
Paris, Ile De France 75010
FranceSite Not Available
Hôpital Saint Louis
Paris, Ile de France 75010
FranceActive - Recruiting
CHU de Nantes
Alexis-Ricordeau, Nantes 44000
FranceSite Not Available
CHU de Montpellier
Montpellier, Occitanie 34295
FranceActive - Recruiting
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Saint-Eloi
Montpellier, Occitanie 34295
FranceSite Not Available
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Saint-Eloi
Montpellier 2992166, Occitanie 11071623 34295
FranceActive - Recruiting
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis - Centre Integre en Cancerologie
Paris 2988507, Île-de-France Region 3012874 75010
FranceActive - Recruiting
Centre Hospitalier Universitaire de Nantes (CHU de Nantes)-Hotel-Dieu
Nantes, 44093
FranceSite Not Available
Centre Hospitalier Universitaire de Nantes (CHU de Nantes)-Hotel-Dieu
Nantes 2990969, 44093
FranceActive - Recruiting
Clínica Universidad de Navarra
Pamplona, Navarra 31008
SpainActive - Recruiting
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
Pamplona, Navarra 31008
SpainSite Not Available
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
Pamplona 3114472, Navarre 3115609 31008
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
Sevilla, 41013
SpainSite Not Available
Hospital Universitario Virgen del Rocío
Sevilla, 41013
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
Seville 2510911, 41013
SpainActive - Recruiting
The University of Chicago Medical Center (UCMC)
Chicago, Illinois 60637
United StatesSite Not Available
University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
The University of Chicago Medical Center (UCMC)
Chicago 4887398, Illinois 4896861 60637
United StatesActive - Recruiting
Harvard Medical School - Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Massachusetts General Hospital: Hematology Oncology
Boston, Massachusetts 02114
United StatesActive - Recruiting
Harvard Medical School - Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey (CINJ) - New Brunswick
New Brunswick, New Jersey 08901
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey (CINJ) - New Brunswick
New Brunswick 5101717, New Jersey 5101760 08901
United StatesActive - Recruiting
Sarah Cannon - St. David South Austin Medical Center
Austin, Texas 78704
United StatesSite Not Available
Sarah Cannon - St. David South Austin Medical Center
Austin 4671654, Texas 4736286 78704
United StatesActive - Recruiting

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