Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma
NCT ID: NCT05607420
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
80 participants
INTERVENTIONAL
2022-11-01
2027-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
RN1201injection for Relapsed/Refractory CD19+/BCMA+ Hematologic Malignancies
NCT07113496
Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia
NCT02746952
Safety and Clinical Activity of ThisCART19 in Patients With r/r Non-Hodgkin's B Cell Lymphoma
NCT05106907
The Clinical Study of CD20 CAR-T Cells in Patients With Relapsed and Refractory B Cell Non-Hodgkin Lymphoma
NCT04169932
L218CAR19 in Patients With Relapsed/Refractory B-cell Lymphoma
NCT06478381
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dose finding part
UCART20x22 tested at several dose levels until the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) is identified.
Dose expansion part: UCART20x22 administered at the RP2D determined during the dose finding part
UCART20x22
Allogeneic engineered T-cells expressing anti-CD20 and anti-CD22 Chimeric Antigen Receptors given following a lymphodepletion regimen
CLLS52
A monoclonal antibody that recognizes a CD52 antigen
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
UCART20x22
Allogeneic engineered T-cells expressing anti-CD20 and anti-CD22 Chimeric Antigen Receptors given following a lymphodepletion regimen
CLLS52
A monoclonal antibody that recognizes a CD52 antigen
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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. 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 with MYC 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's tyrosine kinase (BTK) inhibitor for mantle cell lymphoma (MCL)
* Autologous anti-CD19 CAR T-cell therapy, if approved and available for the indicated lymphoma subtype, unless the subject is unable or is ineligible to receive approved autologous 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 LD regimen if the subject is considered high-risk for prolonged hematologic toxicity.
Exclusion Criteria
* Previous approved therapy including chemotherapy, biologic (except MoAbs), or targeted therapy for R/R B-NHL with 5 half-lives or within 14 days, whichever is shorter, 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 LD regimen
* Prior cell or gene therapy (approved or investigational) within 6 months of the start of LD
* Prior cell or gene therapy (approved or investigational) targeting both CD20 and CD22
* Autologous HSCT infusion within 6 weeks of the start of LD
* Allogeneic HSCT within 3 months of the start of LD, or donor lymphocyte infusion within 6 weeks of the start of LD
* Active acute or chronic graft versus host disease (GvHD). Subjects should be off all immunosuppressive therapies for at least 6 weeks prior to start of LD
* Radiotherapy within 8 weeks (except for palliative radiotherapy for specific on-target lesions) (prior to start of LD regimen)
* Evidence of active central nervous system (CNS) lymphoma or previous CNS involvement of 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 or viral, 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 the cervix)
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cellectis S.A.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeremy Abramson, MD
Role: PRINCIPAL_INVESTIGATOR
Harvard Medical School - Massachusetts General
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
Harvard Medical School - Massachusetts General Hospital
Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey (CINJ) - New Brunswick
New Brunswick, New Jersey, United States
Sarah Cannon - St. David South Austin Medical Center
Austin, Texas, United States
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre-Bénite, Auvergne Rhone Alpe, France
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Saint-Eloi
Montpellier, Occitanie, France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes)-Hotel-Dieu
Nantes, , France
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis - Centre Integre en Cancerologie
Paris, Île-de-France Region, France
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
Pamplona, Navarre, Spain
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UCART20x22_01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.