Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT05607420
Status:
RECRUITING
Last Update Posted:
2025-08-24
First Post:
2022-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074323', 'term': 'Alemtuzumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2022-10-25', 'studyFirstSubmitQcDate': '2022-10-31', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose finding and expansion parts: Incidence of adverse events/serious adverse events/dose limiting toxicity [Safety and Tolerability]', 'timeFrame': 'From study entry through month 12', 'description': 'Incidence, nature and severity of adverse events and serious adverse events in relation to UCART20x22 and/or lymphodepletion'}, {'measure': 'Dose finding part: Occurrence of Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Up to Day 28 post UCART20x22 infusion'}], 'secondaryOutcomes': [{'measure': 'Investigator assessed overall response rate (ORR) according to Lugano Response Criteria for Malignant Lymphoma', 'timeFrame': 'At Day 28, Day 84, Month 6, Month 9, Month 12'}, {'measure': 'Duration of Response', 'timeFrame': 'From achievement of the initial response to disease relapse/progression or death from any cause, assessed up to Month 12'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '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'}, {'measure': 'Overall survival', 'timeFrame': 'From initiation of any study treatment to death from any cause, assessed up to Year 15'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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®)'], 'conditions': ['B-cell Non-Hodgkin Lymphoma (B-NHL)']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Relapsed or refractory (R/R) mature B-NHL per 2016 WHO criteria and positive for CD20 and/or CD22\n* Subjects with NHL subtypes defined by WHO:\n* 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)\n* Dose-Expansion Part: R/R LBCL, defined as:\n\n 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\n* R/R disease after at least 2 lines of prior treatment, which must have included:\n* 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\n* An alkylating agent in combination with an anti-CD20 MoAb for FL\n* An anthracycline or bendamustine-containing chemotherapy regimen and a Bruton's tyrosine kinase (BTK) inhibitor for mantle cell lymphoma (MCL)\n* 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.)\n* 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.\n\nExclusion Criteria:\n\n* 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\n* 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\n* \\> 4 lines of therapy R/R B-NHL prior to start of the LD regimen.\n* Prior MoAb therapy (approved or investigational) within 30 days prior to start of LD\n* Prior systemic immunostimulatory agent within 3 half-lives prior to start of the LD regimen\n* Prior cell or gene therapy (approved or investigational) within 6 months of the start of LD\n* Prior cell or gene therapy (approved or investigational) targeting both CD20 and CD22\n* Autologous HSCT infusion within 6 weeks of the start of LD\n* Allogeneic HSCT within 3 months of the start of LD, or donor lymphocyte infusion within 6 weeks of the start of LD\n* 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\n* Radiotherapy within 8 weeks (except for palliative radiotherapy for specific on-target lesions) (prior to start of LD regimen)\n* Evidence of active central nervous system (CNS) lymphoma or previous CNS involvement of R/R B-NHL\n* Presence of an active and clinically relevant CNS disorder\n* Daily treatment with \\>20 mg prednisone or equivalent\n* Known active infection, or reactivation of a latent infection, whether bacterial or viral, fungal, mycobacterial, or other pathogens\n* History of hypersensitivity to alemtuzumab\n* History of neutralizing anti-drug antibody against alemtuzumab\n* Any known uncontrolled cardiovascular disease within 3 months of enrollment\n* Subjects requiring immunosuppressive treatment\n* Major surgery within 28 days prior to start of LD\n* 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)"}, 'identificationModule': {'nctId': 'NCT05607420', 'acronym': 'NatHaLi-01', 'briefTitle': 'Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cellectis S.A.'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'UCART20x22_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose finding part', 'description': 'UCART20x22 tested at several dose levels until the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) is identified.\n\nDose expansion part: UCART20x22 administered at the RP2D determined during the dose finding part', 'interventionNames': ['Biological: UCART20x22', 'Biological: CLLS52']}], 'interventions': [{'name': 'UCART20x22', 'type': 'BIOLOGICAL', 'description': 'Allogeneic engineered T-cells expressing anti-CD20 and anti-CD22 Chimeric Antigen Receptors given following a lymphodepletion regimen', 'armGroupLabels': ['Dose finding part']}, {'name': 'CLLS52', 'type': 'BIOLOGICAL', 'otherNames': ['Alemtuzumab'], 'description': 'A monoclonal antibody that recognizes a CD52 antigen', 'armGroupLabels': ['Dose finding part']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter Riedell', 'role': 'CONTACT', 'email': 'priedell@medicine.bsd.uchicago.edu', 'phone': '773-834-5903'}, {'name': 'Peter Riedell', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Chicago Medical Center (UCMC)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeremy Abramson', 'role': 'CONTACT', 'email': 'jabramson@mgh.harvard.edu', 'phone': '617-724-9190'}, {'name': 'Jeremy Abramson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Harvard Medical School - Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Matasar', 'role': 'CONTACT', 'email': 'mm3511@cinj.rutgers.edu', 'phone': '732-439-5162'}, {'name': 'Matthew Matasar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rutgers Cancer Institute of New Jersey (CINJ) - New Brunswick', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '78704', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aravind Ramakrishnan', 'role': 'CONTACT', 'email': 'Aravind.Ramakrishnan@hcahealthcare.com', 'phone': '512-816-8078'}, {'name': 'Aravind Ramakrishnan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sarah Cannon - St. David South Austin Medical Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'state': 'Auvergne Rhone Alpe', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel Bachy', 'role': 'CONTACT', 'email': 'emmanuel.bachy@chu-lyon.fr', 'phoneExt': '+330478862205'}, {'name': 'Emmanuel Bachy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '34295', 'city': 'Montpellier', 'state': 'Occitanie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume Cartron', 'role': 'CONTACT', 'email': 'g-cartron@chu-montpellier.fr', 'phone': '(+33)467336733'}, {'name': 'Guillaume Cartron', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Saint-Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas Gastinne', 'role': 'CONTACT', 'email': 'thomas.gastinne@chu-nantes.fr', 'phone': '(+33)240083302'}, {'name': 'Thomas Gastinne', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Nantes (CHU de Nantes)-Hotel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75010', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine Thieblemont', 'role': 'CONTACT', 'email': 'catherine.thieblemont@aphp.fr', 'phone': '(+33)0142499236'}, {'name': 'Catherine Thieblemont', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis - Centre Integre en Cancerologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana Alfonso', 'role': 'CONTACT', 'email': 'aalfonso@unav.es', 'phone': '(+34) 948 255 400'}, {'name': 'Ana Alfonso', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '41013', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose Antonio Perez Simon', 'role': 'CONTACT', 'email': 'josea.perez.simon.sspa@juntadendalucia.es', 'phone': '(+34)955923000'}, {'name': 'Jose Antonio Perez Simon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Cellectis Central Contact', 'role': 'CONTACT', 'email': 'clinicaltrials@cellectis.com', 'phone': '+1 917 580-1088'}], 'overallOfficials': [{'name': 'Jeremy Abramson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard Medical School - Massachusetts General'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cellectis S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}