Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma

Last updated: January 10, 2025
Sponsor: Cellectis S.A.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma, B-cell

Lymphoma

Treatment

CLLS52

UCART20x22

Clinical Study ID

NCT05607420
UCART20x22_01
  • Ages 18-80
  • All Genders

Study 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). 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).

Eligibility Criteria

Inclusion

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 forCD20 and/or CD22

  • Subjects with NHL subtypes defined by WHO:

  • -Dose-Finding Part: R/R mature B-NHL (except chronic lymphocytic leukemia/smalllymphocytic 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 lymphomawith MYC and BCL2 and/or BCL6 rearrangements; iii. Transformed FL or transformedmarginal 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 withMYC 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'styrosine kinase (BTK) inhibitor for mantle cell lymphoma (MCL)

  • -Autologous anti-CD19 CAR T-cell therapy, if approved and available for theindicated lymphoma subtype, unless the subject is unable or is ineligible to receiveapproved autologous anti-CD19 CAR T-cell therapy (e.g., fail leukapheresis ormanufacture, unable to wait for manufacture, CD19 negative disease, etc.)

  • Autologous hematopoietic stem cells must be available prior to the start of the LDregimen if the subject is considered high-risk for prolonged hematologic toxicity

Exclusion

Exclusion Criteria:

  • Prior use of an investigational product (except for cell or gene therapies andMoAbs) within 5 half-lives or within 14 days, whichever is shorter, prior to startof LD regimen

  • Previous approved therapy including chemotherapy, biologic (except MoAbs), ortargeted therapy for R/R B-NHL with 5 half-lives or within 14 days, whichever isshorter, 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 LDregimen

  • Prior cell or gene therapy (approved or investigational) within 6 weeks of the startof LD

  • Prior cell or gene therapy (approved or investigational) targeting both CD20 andCD22

  • Autologous HSCT infusion within 6 weeks of the start of LD

  • Allogeneic HSCT within 3 months of the start of LD, or donor lymphocyte infusionwithin 6 weeks of the start of LD

  • Active acute or chronic graft versus host disease (GvHD). Subjects should be off allimmunosuppressive therapies for at least 6 weeks prior to start of LD

  • Radiotherapy within 8 weeks (except for palliative radiotherapy for specificon-target lesions) (prior to start of LD regimen)

  • Evidence of active central nervous system (CNS) lymphoma or previous CNS involvementof 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 orviral, 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 thecervix)

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: CLLS52
Phase: 1/2
Study Start date:
November 01, 2022
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Hôpital Lyon Sud

    Pierre-Bénite, Auvergne Rhone Alpe 69310
    France

    Active - Recruiting

  • Hôpital Saint Louis

    Paris, Ile de France 75010
    France

    Active - Recruiting

  • CHU de Nantes

    Alexis-Ricordeau, Nantes 44000
    France

    Active - Recruiting

  • CHU de Montpellier

    Montpellier, Occitanie 34295
    France

    Active - Recruiting

  • Clínica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Massachusetts General Hospital: Hematology Oncology

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Sarah Cannon - St. David South Austin Medical Center

    Austin, Texas 78704
    United States

    Active - Recruiting

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