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B-cell Non-Hodgkin Lymphoma (B-NHL)Phase 1/2NatHaLi-01NCT05607420

Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma

A Phase 1/2 study testing UCART20x22 and CLLS52 in people with B-cell Non-Hodgkin Lymphoma (B-NHL), run by Cellectis S.A. at 10 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

First-in-human, open-label, dose-finding and dose-expansion study of UCART20x22 administered intravenously in subjects with relapsed or refractory B-Cell Non-Hodgkin Lymphoma (B-NHL). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
B-cell Non-Hodgkin Lymphoma (B-NHL)
What is being tested?
UCART20x22 and CLLS52
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
10 sitesin 3 countries
Study dates
1 Nov 2022to Aug 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 21Show fewer
  • 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)

Trial locations and contacts

10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Cellectis Central Contact contact

+1 917 580-1088

clinicaltrials@cellectis.com

10 sites in 3 countries

United States4 sites, 4 recruiting

  • Sarah Cannon - St. David South Austin Medical Center

    Austin, Texas, 78704

    Aravind Ramakrishnan, 512-816-8078, Aravind.Ramakrishnan@hcahealthcare.com

    Aravind Ramakrishnan

    Recruiting

  • Harvard Medical School - Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Jeremy Abramson, 617-724-9190, jabramson@mgh.harvard.edu

    Jeremy Abramson

    Recruiting

  • The University of Chicago Medical Center (UCMC)

    Chicago, Illinois, 60637

    Peter Riedell, 773-834-5903, priedell@medicine.bsd.uchicago.edu

    Peter Riedell

    Recruiting

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

    New Brunswick, New Jersey, 08901

    Matthew Matasar, 732-439-5162, mm3511@cinj.rutgers.edu

    Matthew Matasar

    Recruiting

Other trials in United States

France4 sites, 4 recruiting

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

    Montpellier, Occitanie, 34295

    Guillaume Cartron, (+33)467336733, g-cartron@chu-montpellier.fr

    Guillaume Cartron

    Recruiting

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

    Nantes, 44093

    Thomas Gastinne, (+33)240083302, thomas.gastinne@chu-nantes.fr

    Thomas Gastinne

    Recruiting

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

    Paris, Île-de-France Region, 75010

    Catherine Thieblemont, (+33)0142499236, catherine.thieblemont@aphp.fr

    Catherine Thieblemont

    Recruiting

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

    Pierre-Bénite, Auvergne Rhone Alpe, 69310

    Emmanuel Bachy, emmanuel.bachy@chu-lyon.fr

    Emmanuel Bachy

    Recruiting

Other trials in France

Spain2 sites, 2 recruiting

  • Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona

    Pamplona, Navarre, 31008

    Ana Alfonso, (+34) 948 255 400, aalfonso@unav.es

    Ana Alfonso

    Recruiting

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

    Seville, 41013

    Jose Antonio Perez Simon, (+34)955923000, josea.perez.simon.sspa@juntadendalucia.es

    Jose Antonio Perez Simon

    Recruiting

Other trials in Spain

About this study

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)

First-in-human, open-label, dose-finding and dose-expansion study of UCART20x22 administered intravenously in subjects with relapsed or refractory B-Cell Non-Hodgkin Lymphoma (B-NHL). The purpose of this study is to evaluate the safety and clinical activity of UCART20x22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).

Being tested
UCART20x22, CLLS52
Keywords
B-cell Non-Hodgkin Lymphoma (B-NHL), Relapsed/Refractory B-NHL, Universal Chimeric Antigen Receptor T-Cell (UCAR-T) Therapy, Allogeneic, Transcription Activator-Like Effector Nuclease (TALEN®)
Medical subject headings
Lymphoma, B-Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UCART20x22Biological

    Allogeneic engineered T-cells expressing anti-CD20 and anti-CD22 Chimeric Antigen Receptors given following a lymphodepletion regimen

  • CLLS52Biological

    Also called Alemtuzumab

    A monoclonal antibody that recognizes a CD52 antigen

Study groups in NCT05607420
Study groupRoleWhat they receive
Dose finding partExperimentalUCART20x22 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
Receives: Biological: UCART20x22; Biological: CLLS52

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose finding and expansion parts: Incidence of adverse events/serious adverse events/dose limiting toxicity [Safety and Tolerability]

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

    Measured: From study entry through month 12

  2. Dose finding part: Occurrence of Dose Limiting Toxicities (DLTs)

    Measured: Up to Day 28 post UCART20x22 infusion

Secondary outcomes (4)

  1. Investigator assessed overall response rate (ORR) according to Lugano Response Criteria for Malignant Lymphoma

    Measured: At Day 28, Day 84, Month 6, Month 9, Month 12

  2. Duration of Response

    Measured: From achievement of the initial response to disease relapse/progression or death from any cause, assessed up to Month 12

  3. Progression-free survival (PFS)

    Measured: From the first day of any study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 12

  4. Overall survival

    Measured: From initiation of any study treatment to death from any cause, assessed up to Year 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2022
  2. Study start1 Nov 2022
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05607420
Sponsor's protocol ID
UCART20x22_01
Acronym
NatHaLi-01
Status last verified
Aug 2025
First submitted
25 Oct 2022
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing UCART20x22 and CLLS52 in people with B-cell Non-Hodgkin Lymphoma (B-NHL), run by Cellectis S.A. at 10 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cellectis Central Contact (+1 917 580-1088, clinicaltrials@cellectis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose finding and expansion parts: Incidence of adverse events/serious adverse events/dose limiting toxicity [Safety and Tolerability] (time frame: From study entry through month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05607420.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.

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