Evaluating a new treatment for B-cell Non-Hodgkin Lymphoma
Official title: 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)
Run by Cellectis S.A. · NCT05607420 · Data updated 2026-11-12
This study is testing a new CAR-T therapy called UCART20x22 to see if it can help people with relapsed or hard-to-treat B-cell Non-Hodgkin Lymphoma.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Cellectis S.A. Industry-sponsored |
| Drugs / interventions | alemtuzumab, CAR T, chemotherapy, prednisone |
| Locations | 10 sites (Chicago, Illinois and 9 other locations) |
| Status | Recruiting |
| Started | November 1, 2022 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | August 24, 2025 |
| Trial ID | NCT05607420 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma who have undergone at least two prior lines of treatment.
✕Probably not a fit
Patients with chronic lymphocytic leukemia, Burkitt's lymphoma, or those who have not received prior anti-CD20 therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is an open-label, dose-finding and dose-expansion study of UCART20x22, a novel allogeneic CAR-T therapy, administered intravenously to patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL). The study aims to assess the safety and clinical activity of UCART20x22, determining the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D). Participants will be monitored for their response to the treatment and any adverse effects.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell Non-Hodgkin Lymphoma.
How similar studies have gone: Other studies utilizing CAR-T therapies have shown promising results, indicating potential success for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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. 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: * Prior use of an investigational product (except for cell or gene therapies and MoAbs) within 5 half-lives or within 14 days, whichever is shorter, prior to start of LD regimen * 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)
Where it's running
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The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States Recruiting -
Harvard Medical School - Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
Rutgers Cancer Institute of New Jersey (CINJ) - New Brunswick
New Brunswick, New Jersey, United States Recruiting -
Sarah Cannon - St. David South Austin Medical Center
Austin, Texas, United States Recruiting -
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre-Bénite, Auvergne Rhone Alpe, France Recruiting -
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Saint-Eloi
Montpellier, Occitanie, France Recruiting
Show 4 more locations
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Centre Hospitalier Universitaire de Nantes (CHU de Nantes)-Hotel-Dieu
Nantes, France Recruiting -
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis - Centre Integre en Cancerologie
Paris, Île-de-France Region, France Recruiting -
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
Pamplona, Navarre, Spain Recruiting -
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
Seville, Spain Recruiting
Study contacts
- Principal investigator: Jeremy Abramson, MD — Harvard Medical School - Massachusetts General
- Study coordinator: Cellectis Central Contact
- Email: clinicaltrials@cellectis.com
- Phone: +1 917 580-1088
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating AcNK-Sup003 Cell Injection for B-cell Non-Hodgkin's Lymphoma
This study is testing if a new type of cell injection can help people with hard-to-treat B-cell non-Hodgkin's lymphoma by boosting the body's natural killer cells to fight the cancer.
-
Testing a new CAR T cell therapy for adolescents and adults with relapsed B-cell Non-Hodgkin Lymphoma
This study is testing a new CAR T cell therapy to see if it can help adolescents and adults with relapsed B-cell Non-Hodgkin Lymphoma feel better and improve their chances of recovery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.