Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-27 @ 2:26 AM
Study NCT ID:
NCT05741359
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2023-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Total target count of CD3+CAR+ viable cells'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT', 'timeFrame': 'Within 28 Days After BRL-201 Infusion', 'description': 'The number and severity of dose-limiting toxicity (DLT) events'}, {'measure': 'AEs', 'timeFrame': 'Up to 24 Months After BRL-201 Infusion', 'description': 'The total number, incidence, and severity of AEs'}, {'measure': 'RP2D', 'timeFrame': 'Within 28 Days After BRL-201 Infusion', 'description': 'The recommended phase 2 dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-hodgkin Lymphoma,B Cell']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects.', 'detailedDescription': 'This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C. Additional subjects will be enrolled into the RP2D group to ensure that 6-9 efficacy-evaluable subjects are available in the RP2D group before entering the phase II study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Willing to participate in this clinical study and sign an informed consent form;\n2. Age ≥ 18 years old;\n3. Estimated survival time ≥ 3 months;\n4. Presence of at least one measurable lesion as assessed according to Lugano Classification 2014 for response assessment in lymphomas (i.e., the cross-sectional images obtained by CT show that the long diameter of lymph node lesions is \\> 15 mm or the long diameter of extranodal lesions is \\> 10 mm, and FDG-PET scan results are positive). Lesions, for which radiotherapy was provided, can be regarded as measurable lesions only if there is an unequivocal progression after radiotherapy;\n5. Histopathologically confirmed aggressive B-NHL; positive expression of CD19 in tumors detected by immunohistochemistry or flow cytometry; pathological types of B-NHL (according to WHO Lymphoma Classification 2016);\n6. Relapsed or refractory diseases;\n7. Subjects who must receive adequate prior therapy;\n8. Absence of invasion of central nervous system (CNS) lymphoma by cranial magnetic resonance imaging (MRI);\n9. Hematological parameters meeting the requirements;\n10. Blood biochemistry meeting the requirements;\n11. LVEF ≥ 55%;\n12. No severe pulmonary disorders;\n13. Toxic reactions induced by prior anti-lymphoma therapy must be stable and resolved to grade ≤ 1;\n14. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n15. Patients with physical conditions for apheresis of peripheral blood; 16 . Willing to abide by the rules formulated in the study protocol.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Subjects who previously received allogeneic cell therapies, including allogeneic stem cell transplant;\n3. Subjects who previously received anti-CD19 targeted therapy, except those who receive BRL-201 and are eligible to receive reinfusion in this study;\n4. Prior treatment with any CAR-T cell product or other genetically modified T cell therapies;\n5. History of Richter's transformation of chronic lymphocytic leukemia (CLL);\n6. Presence of uncontrollable fungal, bacterial, viral, or other infections requiring systemic therapy. Patients can be enrolled if the simple urinary tract infection or pharyngitis responds to treatment;\n7. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;\n8. Severe mental disorders; history of CNS disorders (e.g., epileptic seizure, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any CNS-involved autoimmune disorders);\n9. Active autoimmune disorders requiring immunotherapy, including but not limited to end organ damages caused by autoimmune disorders (e.g., Crohn's disease, rheumatoid arthritis, and systemic lupus erythematosus) in the past 2 years, or requiring systemic application of immunosuppressive drugs or other drugs for systemic control of diseases;\n10. Primary immunodeficiency;\n11. History of other malignancies;\n12. Patients with severe cardiovascular disorders, including but not limited to those with lymphoma infiltration in the cardiac atrium or ventricles and those with a history of myocardial infarction, cardioangioplasty or stent implantation, unstable angina, or other clinically significant heart diseases within 12 months before enrollment;\n13. History of deep venous thrombosis or pulmonary embolism within 6 months before enrollment;\n14. Patients who are receiving oral anticoagulant therapy; prothrombin time (PT), activated partial thromboplastin time (APTT), or international normalized ratio (INR) \\> 1.5 × ULN without anticoagulant therapy;\n15. Presence of any indwelling tube or catheter (e.g., tube or catheter for percutaneous nephrostomy, indwelling catheter, or catheter in pleural cavity/peritoneal cavity/pericardium). Dedicated central venous access catheters (e.g., Port-a-Cath or Hickman catheter) are permitted;\n16. Lymphoma cells detected in cerebrospinal fluid, presence of brain metastases, history of CNS lymphoma, or history of lymphoma cells detected in cerebrospinal fluid or brain metastases;\n17. Conditions (e.g., intestinal obstruction or vascular compression) requiring emergency treatment due to tumor masses;\n18. History of severe immediate hypersensitivity to any drug to be used in this study;\n19. Vaccination of live vaccines, excluding corona virus disease 2019 (COVID-19) vaccines, within ≤ 6 weeks before the start of the pretreatment regimen;\n20. Any circumstances that possibly increase the risk of subjects or interfere with the study results as judged by the investigator."}, 'identificationModule': {'nctId': 'NCT05741359', 'briefTitle': 'The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bioray Laboratories'}, 'officialTitle': 'A Phase I/II Clinical Study of the Safety and Efficacy of CD19-targeted Non-viral PD1 Site-specific Integrated CAR-T Cell Injection (BRL-201) in the Treatment of Relapsed or Refractory B Lymphocyte Non-Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': '2022-BRL-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': '5- 10.0×10\\^6/kgBW', 'interventionNames': ['Drug: CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection']}], 'interventions': [{'name': 'CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection', 'type': 'DRUG', 'otherNames': ['BRL-201'], 'description': 'CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Heng Mei, PhD', 'role': 'CONTACT'}], 'facility': 'Wuhan Union Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rugui qiu, PhD', 'role': 'CONTACT'}], 'facility': 'Tianjin Institute of Hematology', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'He Huang, PhD', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Wei Li, PhD', 'role': 'CONTACT', 'email': 'wli@brlmed.com', 'phone': '18621670308'}], 'overallOfficials': [{'name': 'Wei Li', 'role': 'STUDY_CHAIR', 'affiliation': 'Bioray Laboratories'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioray Laboratories', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, {'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}