Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma

Trial Title: Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma

NCT ID: NCT05607420

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

Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Alemtuzumab

Conditions: 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®)

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: UCART20x22
Description: Allogeneic engineered T-cells expressing anti-CD20 and anti-CD22 Chimeric Antigen Receptors given following a lymphodepletion regimen
Arm group label: Dose finding part

Intervention type: Biological
Intervention name: CLLS52
Description: A monoclonal antibody that recognizes a CD52 antigen
Arm group label: Dose finding part

Other name: Alemtuzumab

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).

Criteria for eligibility:
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 - 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 weeks 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)

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of Chicago

Address:
City: Chicago
Zip: 60637
Country: United States

Status: Recruiting

Facility:
Name: Massachusetts General Hospital

Address:
City: Boston
Zip: 02114
Country: United States

Status: Recruiting

Facility:
Name: Rutgers Cancer Institute of New Jersey

Address:
City: New Brunswick
Zip: 08901
Country: United States

Status: Recruiting

Facility:
Name: Sarah Cannon - St. David South Austin Medical Center

Address:
City: Austin
Zip: 78704
Country: United States

Status: Recruiting

Facility:
Name: Hôpital Lyon Sud

Address:
City: Pierre-Bénite
Zip: 69310
Country: France

Status: Recruiting

Facility:
Name: Hôpital Saint Louis

Address:
City: Paris
Zip: 75010
Country: France

Status: Recruiting

Facility:
Name: CHU de Montpellier

Address:
City: Montpellier
Zip: 34295
Country: France

Status: Recruiting

Facility:
Name: Clínica Universidad de Navarra

Address:
City: Pamplona
Zip: 31008
Country: Spain

Status: Recruiting

Facility:
Name: Hospital Universitario Virgen del Rocío

Address:
City: Sevilla
Zip: 41013
Country: Spain

Status: Recruiting

Start date: November 1, 2022

Completion date: November 2027

Lead sponsor:
Agency: Cellectis S.A.
Agency class: Industry

Source: Cellectis S.A.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05607420