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Evaluating a new treatment for B-cell Non-Hodgkin Lymphoma

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)

Phase1; Phase2 Interventional Cellectis S.A. · NCT05607420

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

PhasePhase1; Phase2
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorCellectis S.A. Industry-sponsored
Drugs / interventionsalemtuzumab, CAR T, chemotherapy, prednisone
Locations10 sites (Chicago, Illinois and 9 other locations)
Trial IDNCT05607420 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Other studies utilizing CAR-T therapies have shown promising results, indicating potential success for this novel approach.

Eligibility criteria

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 this trial is running

Chicago, Illinois and 9 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions B-cell Non-Hodgkin LymphomaRelapsed/Refractory B-NHLUniversal Chimeric Antigen Receptor T-Cell TherapyAllogeneicTranscription Activator-Like Effector Nuclease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.