Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
Study NCT ID:
NCT05659628
Status:
RECRUITING
Last Update Posted:
2022-12-21
First Post:
2022-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CD19 CAR-T Expressing IL-7 and CCL19 Combined With Anti-PD1 in RR-DLBCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-12', 'studyFirstSubmitDate': '2022-11-26', 'studyFirstSubmitQcDate': '2022-12-12', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events profile', 'timeFrame': 'Measured from start of treatment until 28 days after last dose.', 'description': 'Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated.'}, {'measure': 'Objective Response Rate', 'timeFrame': 'up to 3 months', 'description': 'Proportion of CR and PR subjects will be assessed at 3 months post-infusion.'}], 'secondaryOutcomes': [{'measure': 'Progress free survival time', 'timeFrame': 'up to 24 months', 'description': 'To measure the duration of response over a follow-up period of 24 months.'}, {'measure': 'Overall survival', 'timeFrame': 'up to 24 months', 'description': 'OS will be assessed from the first chimeric antigen receptor T cells (CAR-T) given to death or last follow-up.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diffuse Large B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test CD19-7×19 CAR-T cells combined with Tislelizumab in refractory and relapsed diffuse large B lymphoma. The main question\\[s\\] it aims to answer are:\n\nquestion 1：What is the safety of CD19-7×19 CAR-T cells combined with Tislelizumab in the treatment of relapsed or refractory diffuse large B-cell lymphoma.\n\nquestion 2：What is the efficacy of CD19-7×19 CAR-T cells combined with Tislelizumab in the treatment of relapsed or refractory diffuse large B-cell lymphoma.\n\nParticipants will be asked to receive clinical evaluation before CAR-T, including physical examination, blood routine test, biochemical test, imaging test, etc.Peripheral blood lymphocytes will be collected for preparation of CAR-T cells after enrollment. Pretreatment chemotherapy with fludarabine and cyclophosphamide will be used before CAR-T infusion. On the 31st day after CAR-T infusion, Tislelizumab 200mg was given once every 21 days for 6 cycles. Participants will be required to report concomitant medication and adverse events, and their disease was evaluated throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18, upper limit 75, male or female;\n2. ECOG score 0-3;\n3. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) \\[diagnostic criteria according to WHO 2008\\];\n4. CD19 positive (immunohistochemistry or flow cytometry).\n5. DLBCL refractory or relapse is defined as: complete remission is not achieved after 2-line treatment; let What disease progress occurs during treatment, or the disease stability time is equal to or less than 6 months; Or autologous hematopoietic stem Disease progression or recurrence within 12 months after cell transplantation;\n6. Previous treatment for patients with diffuse large B cell lymphoma must include rituximab (CD20 monoclonal antibody) and anthracyclines;\n7. At least one measurable lesion is required, and any lymph node lesion with a length greater than 1.5cm or extranodal lesion is required If any length diameter is greater than 1.0 cm, the lesions on PET-CT scan have uptake (SUV is larger than liver blood pool);\n8. Absolute value of peripheral blood neutrophils ≥ 1000/ μ l. Platelets ≥ 45000/ μ l\n9. Heart, liver and kidney functions: creatinine \\< 1.5mg/dL; ALT/AST Less than 2.5 times of normal upper limit; Total bilirubin \\< 1.5mg/dL; Cardiac ejection fraction (EF) ≥ 50%;\n10. Have sufficient understanding and voluntarily sign the informed consent form;\n11. People with fertility must be willing to use contraceptive methods;\n12. According to the judgment of the researcher, the expected survival period is at least 4 months;\n13. Willing to follow the visit schedule, administration plan, laboratory inspection and other test steps.\n\nExclusion Criteria:\n\n1. Have a history of other tumors;\n2. Autologous hematopoietic stem cell transplantation was performed within 6 weeks;\n3. Any target CAR-T treatment was performed within 3 months before this CAR-T treatment;\n4. Previously used any commercially available PD-1 monoclonal antibody;\n5. Cytotoxic drugs, glucocorticoids and other targeted drugs were received within 2 weeks before cell collection;\n6. Active autoimmune diseases;\n7. Uncontrollable active bacterial and fungal infections;\n8. HIV infection and syphilis infection; Active hepatitis B or hepatitis C: hepatitis B: HBV-DNA ≥ 1000 IU/mL; Hepatitis C: HCV RNA is positive and liver function is abnormal.\n9. Known central nervous system lymphoma.'}, 'identificationModule': {'nctId': 'NCT05659628', 'briefTitle': 'CD19 CAR-T Expressing IL-7 and CCL19 Combined With Anti-PD1 in RR-DLBCL', 'organization': {'class': 'OTHER', 'fullName': 'Ningbo No. 1 Hospital'}, 'officialTitle': 'Phase Ib Clinical Study of CD19 CAR-T Expressing IL-7 and CCL19 Combined With Tislelizumab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma', 'orgStudyIdInfo': {'id': 'Ningbo101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAR-T combined with anti-PD1 treatment group', 'description': 'CD19-7×19 CAR-T combined with Tislelizumab', 'interventionNames': ['Combination Product: CD19-7×19 CAR-T combined with Tislelizumab']}], 'interventions': [{'name': 'CD19-7×19 CAR-T combined with Tislelizumab', 'type': 'COMBINATION_PRODUCT', 'description': 'Participants will receive 2×106/Kg CD19-7×19 CAR-T cells infusion and Tislelizumab 200mg every 21 days for 6 cycle on the 31st day after CAR-T infusion.', 'armGroupLabels': ['CAR-T combined with anti-PD1 treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenbin Qian, Doctor', 'role': 'CONTACT', 'email': 'qianwb@zju.edu.cn', 'phone': '86-571-87581969'}], 'facility': 'The Second Affiliated Hospital of Zhejiang University, Ningbo First Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '315010', 'city': 'Ningbo', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lixia Sheng, doctor', 'role': 'CONTACT', 'email': 'slx800408@163.com', 'phone': '86-574-87085596'}], 'facility': 'Ningbo First Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}], 'centralContacts': [{'name': 'Lixia Sheng, doctor', 'role': 'CONTACT', 'email': 'slx800408@163.com', 'phone': '86-574-87085596'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ningbo No. 1 Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhejiang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}