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Study of UCART20x22 for B-Cell Non-Hodgkin Lymphoma

This study is testing a new treatment called UCART20x22 for people with B-cell Non-Hodgkin Lymphoma (B-NHL) that has come back or not responded to previous treatments. UCART20x22 is a type of CAR T-cell therapy, which means it uses specially engineered immune cells to fight cancer. Participants will also receive CLLS52, another biological therapy. The main goals are to find a safe dose of UCART20x22 and see how well it works. You may be able to join if you are between 18 and 80 years old, have B-NHL that is positive for CD20 and/or CD22, and meet other health requirements. The study plans to enroll 80 people, but its current status is unclear.

Study design
This is a first-in-human, open-label study, meaning both you and your doctors will know what treatment you are receiving. It is designed to find the right dose and then expand to learn more about the treatment, with a planned enrollment of 80 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and side effects will be monitored from the start of the study through month 12. Dose-limiting toxicities will be specifically tracked for up to 28 days after receiving UCART20x22.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05607420

Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma

Recruiting
PHASE1Ages 18–80InterventionalTreatment
Cellectis S.A.
~80 participants
Updated 2025-08-24 on ClinicalTrials.gov
What's tested:UCART20x22CLLS52

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose finding and expansion parts: Incidence of adverse events/serious adverse events/dose limiting toxicity [Safety and Tolerability]
Measured over From study entry through month 12
+1 more outcome measured

Conditions

B-cell Non-Hodgkin Lymphoma (B-NHL)

Explore related trials

B-Cell Non-Hodgkin Lymphoma

NCT05607420

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis - Centre Integre en Cancerologie

    Paris, Île-de-France Region, Francestudy coordinator listed

    Recruiting

  • Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Saint-Eloi

    Montpellier, Occitanie, Francestudy coordinator listed

    Recruiting

  • Centre Hospitalier Universitaire de Nantes (CHU de Nantes)-Hotel-Dieu

    Nantes, Francestudy coordinator listed

    Recruiting

  • Harvard Medical School - Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

    Pierre-Bénite, Auvergne Rhone Alpe, Francestudy coordinator listed

    Recruiting

  • Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)

    Seville, Spainstudy coordinator listed

    Recruiting

  • Rutgers Cancer Institute of New Jersey (CINJ) - New Brunswick

    New Brunswick, New Jerseystudy coordinator listed

    Recruiting

  • Sarah Cannon - St. David South Austin Medical Center

    Austin, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jeremy Abramson, MD · PRINCIPAL_INVESTIGATOR · Harvard Medical School - Massachusetts General

Who to contact

Cellectis Central Contact
[email protected]
+1 917 580-1088
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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:
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

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)

What this trial measures

  • Dose finding and expansion parts: Incidence of adverse events/serious adverse events/dose limiting toxicity [Safety and Tolerability]From study entry through month 12

    Incidence, nature and severity of adverse events and serious adverse events in relation to UCART20x22 and/or lymphodepletion

  • Dose finding part: Occurrence of Dose Limiting Toxicities (DLTs)Up to Day 28 post UCART20x22 infusion