Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2026-01-01 @ 12:56 AM
Study NCT ID:
NCT07031700
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-22
First Post:
2025-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for r/r FL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707970', 'term': 'tislelizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Identification of candidate biomarkers associated with treatment response based on RNA-seq and/or whole exome sequencing (WES) data', 'timeFrame': 'up to 2 years', 'description': 'Tumor and/or blood samples will be collected at baseline and during treatment. RNA sequencing (RNA-seq) and/or whole exome sequencing (WES) will be performed to identify gene expression signatures, somatic mutations, or pathway alterations that correlate with clinical response (e.g., CR/PR vs. SD/PD) to the combination therapy of Mosunetuzumab and Tislelizumab.'}], 'primaryOutcomes': [{'measure': 'best of complete response rate (CR)', 'timeFrame': 'up to the end of 8/17 cycles of treatment(each cycle 21 days)', 'description': 'To assess the best of complete response rate (CR) at the end of treatment of Mosunetuzumab with Tislelizumab'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'up to the end of 8/17 cycles of treatment(each cycle 21 days)', 'description': 'Objective Response Rate is defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) after treatment with Mosunetuzumab and Tislelizumab, as assessed according to Lugano 2014 criteria.'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'up to 2 years', 'description': 'Duration of Response is defined as the time from the first documentation of objective response (CR or PR) to the first documentation of disease progression or death from any cause, whichever occurs first. Response will be assessed per Lugano 2014 criteria.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Assessed every 3 months during follow-up, up to 2 years', 'description': 'Progression-Free Survival is defined as the time from initiation of study treatment to disease progression or death from any cause, whichever occurs first.'}, {'measure': 'OS', 'timeFrame': 'Assessed every 3 months during follow-up, up to 2 years', 'description': 'Overall Survival is defined as the time from initiation of study treatment to death from any cause.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed/Refractory Follicular Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, single-arm, open-label, investigator-initiated, phase II clinical trial designed to evaluate the feasibility, efficacy, and safety of Mosunetuzumab in combination with Tislelizumab in patients with relapsed/refractory follicular lymphoma (r/r FL).', 'detailedDescription': 'The study aims to enroll approximately 22 adult patients who have received at least two prior systemic therapies, including anti-CD20 monoclonal antibody treatment. The primary endpoint is the complete response rate (CR), while secondary endpoints include objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety assessment. The trial will be conducted at multiple centers in China, with an estimated study duration from May 2025 to May 2027.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed written informed consent.\n2. Age ≥18 years.\n3. Histologically confirmed relapsed/refractory follicular lymphoma (r/r FL).\n4. Received at least two prior systemic therapies, including anti-CD20 monoclonal antibody therapy.\n5. ECOG performance status 0-1.\n6. Expected survival ≥12 weeks.\n7. Measurable disease (longest diameter \\>1.5 cm).\n8. Adequate organ function:\n\n * Hepatic function: Total bilirubin ≤1.5×ULN; AST/ALT ≤3×ULN.\n * Hematologic function: ANC ≥1.5 × 10⁹/L; Platelets ≥75,000/μL; Hemoglobin ≥10.0 g/dL.\n * Renal function: Serum creatinine ≤1.5×ULN or CrCl ≥50 mL/min (Cockcroft-Gault formula).\n9. Women of childbearing potential must have a negative serum pregnancy test and agree to use contraception.\n\nExclusion Criteria:\n\n1. Inability to comply with study hospitalization and restrictions.\n2. Active infections (including tuberculosis) or immunocompromised status.\n3. Prior history of severe hypersensitivity to similar agents.\n4. CNS involvement of lymphoma.\n5. Pregnant or breastfeeding women.\n6. Uncontrolled comorbid conditions, including cardiovascular or autoimmune diseases.\n7. Receipt of live attenuated vaccines within 4 weeks before enrollment.\n8. Use of systemic immunosuppressants within 2 weeks prior to first dose.\n9. History of drug or alcohol abuse in the past 12 months.\n10. Any condition deemed inappropriate for study participation by the investigator.'}, 'identificationModule': {'nctId': 'NCT07031700', 'briefTitle': 'A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for r/r FL', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for Relapsed/Refractory Follicular Lymphoma (r/r FL)', 'orgStudyIdInfo': {'id': 'FL-RR-MOS01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'combination therapy of Mosunetuzumab and Tislelizumab', 'interventionNames': ['Drug: Mosunetuzumab', 'Drug: Tislelizumab']}], 'interventions': [{'name': 'Mosunetuzumab', 'type': 'DRUG', 'description': '* Cycle 1: Day 1: 1 mg; Day 8: 2 mg; Day 15: 30 mg\n* Cycles 2-8: 30 mg every 3 weeks\n* Cycles 9-17: 30 mg every 3 weeks (if applicable） A treatment cycle is 21 days. Patients achieving complete remission (CR) by cycle 8 will stop treatment, while those with partial response (PR) or stable disease (SD) may continue up to 17 cycles or until disease progression or intolerable toxicity occurs.', 'armGroupLabels': ['combination therapy of Mosunetuzumab and Tislelizumab']}, {'name': 'Tislelizumab', 'type': 'DRUG', 'description': '\\- Cycles 2-8: 200 mg IV every 3 weeks', 'armGroupLabels': ['combination therapy of Mosunetuzumab and Tislelizumab']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Huilai Zhang', 'role': 'CONTACT', 'email': 'huilaizhangtz@163.com', 'phone': '+86-18622221228'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of lymphoma department', 'investigatorFullName': 'Huilai Zhang', 'investigatorAffiliation': 'Tianjin Medical University Cancer Institute and Hospital'}}}}