RecruitingPhase 1Phase 2NCT05607420

Study Evaluating UCART20x22 in 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)

Sponsor

Cellectis S.A.

Enrollment

80 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of cell therapy called UCART20x22 — immune cells from a healthy donor that are engineered to attack cancer cells carrying the CD20 and/or CD22 markers — for people with relapsed or treatment-resistant B-cell non-Hodgkin lymphoma (a blood cancer). **You may be eligible if...** - You have relapsed or refractory mature B-cell non-Hodgkin lymphoma (B-NHL) that is positive for CD20 and/or CD22 - Your performance status is ECOG 0 or 1 - Depending on the study cohort, eligible subtypes include DLBCL, high-grade B-cell lymphoma, transformed follicular lymphoma, and others **You may NOT be eligible if...** - You have certain lymphoma subtypes including CLL/SLL, Burkitt lymphoma, or Waldenstrom's macroglobulinemia - Your overall health is too poor to tolerate this treatment - You have significant organ problems or active infections (check full protocol with your doctor) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALUCART20x22

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

BIOLOGICALCLLS52

A monoclonal antibody that recognizes a CD52 antigen

Locations(10)

The University of Chicago Medical Center (UCMC)

Chicago, Illinois, United States

Harvard Medical School - Massachusetts General Hospital

Boston, Massachusetts, United States

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

New Brunswick, New Jersey, United States

Sarah Cannon - St. David South Austin Medical Center

Austin, Texas, United States

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

Pierre-Bénite, Auvergne Rhone Alpe, France

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

Montpellier, Occitanie, France

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

Nantes, France

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

Paris, Île-de-France Region, France

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

Pamplona, Navarre, Spain

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

Seville, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05607420

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