Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma

NCT05607420 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: UCART20x22_01
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 10

Brief 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).

Conditions

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

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®)

Outcome Measures

Primary Outcomes (2)

• 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

  From study entry through month 12

• Dose finding part: Occurrence of Dose Limiting Toxicities (DLTs)

  Up to Day 28 post UCART20x22 infusion

Secondary Outcomes (4)

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

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

• Duration of Response

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

• Progression-free survival (PFS)

  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

• Overall survival

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

Study Arms (1)

Dose finding part

EXPERIMENTAL

UCART20x22 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

Biological: UCART20x22; Biological: CLLS52

Interventions

UCART20x22 BIOLOGICAL

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

Dose finding part

CLLS52 BIOLOGICAL

A monoclonal antibody that recognizes a CD52 antigen

Also known as: Alemtuzumab

Dose finding part

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cellectis S.A.: lead

Study Sites (10)

The University of Chicago Medical Center (UCMC)

Chicago, Illinois, 60637, United States

RECRUITING

Harvard Medical School - Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

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

New Brunswick, New Jersey, 08901, United States

RECRUITING

Sarah Cannon - St. David South Austin Medical Center

Austin, Texas, 78704, United States

RECRUITING

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

Pierre-Bénite, Auvergne Rhone Alpe, 69310, France

RECRUITING

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

Montpellier, Occitanie, 34295, France

RECRUITING

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

Nantes, 44093, France

RECRUITING

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

Paris, Île-de-France Region, 75010, France

RECRUITING

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

Pamplona, Navarre, 31008, Spain

RECRUITING

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

Seville, 41013, Spain

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Recurrence

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jeremy Abramson, MD

  Harvard Medical School - Massachusetts General

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cellectis Central Contact

CONTACT

+1 917 580-1088; clinicaltrials@cellectis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 7, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); ES (2); US (4)