Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
Study NCT ID:
NCT06822868
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2025-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory 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'}], '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': 'D016219', 'term': 'Immunotherapy, Adoptive'}], 'ancestors': [{'id': 'D019264', 'term': 'Adoptive Transfer'}, {'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, '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': '2025-02-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events (AE) after CT1190B infusion', 'timeFrame': '12 months after CT1190B infusion', 'description': 'An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria'}, {'measure': 'MTD and/or dose range', 'timeFrame': 'Up to 28 days after CAR-T cells infusion', 'description': 'Evaluate Dose limited toxicity and recommended dosage range after CT0991 infusion.'}], 'secondaryOutcomes': [{'measure': 'Overall response rate（ORR）', 'timeFrame': 'Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion', 'description': 'The proportion of patients with complete remission （CR） /partial response (PR) after CT1190B infusion.'}, {'measure': 'Complete response rate (CRR)', 'timeFrame': '12 months after CT1190B infusion', 'description': 'The proportion of patients with complete response(CR) after CT1190B infusion'}, {'measure': 'Duration of remission(DOR)', 'timeFrame': '12 months after CT1190B infusion', 'description': 'Participants achieving CR/PR will be included in the analysis set for DOR. DOR is defined as the time from the date of confirmed response until the date of disease relapse or death from any cause, whichever occurs first.'}, {'measure': 'Time to response (TTR)', 'timeFrame': '12 months after CT1190B infusion', 'description': 'The time from cell infusion to the first assessment of CR or PR'}, {'measure': 'Time to complete response (TTCR)', 'timeFrame': '12 months after CT1190B infusion', 'description': 'The time from cell infusion to the first assessment of CR'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '12 months after CT1190B infusion', 'description': 'The time from the infusion of CT1190B cells to the first assessment of disease progression or death.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '12 months after CT1190B infusion', 'description': 'defined as the time from the date of receiving the infusion to the date of death from any cause'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CT1190B'], 'conditions': ['B-Cell Non-Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell therapy, in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma.', 'detailedDescription': 'This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT1190B cells in patients with B-NHL. It is planned to enroll 6-24 participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participants must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the study visit schedule and other protocol requirements and agree to be in long term follow-up (LTFU) for up to 15 years as mandated by the regulatory guidelines.\n2. 18-75 years old;\n3. Histologically or cytologically confirmed B-NHL;\n4. Previously received at least 2 lines of systemic therapy;\n5. Intolerance to last treatment, or have progressed on or after the last treatment and currently require therapy;\n6. There are measurable target lesions;\n7. Expected survival \\> 12 weeks;\n8. Eastern Cooperative Oncology Group (ECOG) score 0-1;\n9. Female participants of childbearing potential must have a negative pregnancy test at screening and prior to receiving preconditioning therapy and are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment and are absolutely prohibited from donating eggs for 1 year after receiving study treatment infusion during the study; male participants are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment if they are sexually active with a female of childbearing potential. Sperm donation is absolutely prohibited for 1 year after receiving study treatment infusions during the study for all male participants.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Has HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis C virus infection (HCV antibody and HCV-DNA positive);\n3. Has any current uncontrolled active infection, including but not limited to participants with active tuberculosis (investigator 's judgment);\n4. Participants' toxicities caused by previous treatment did not recover to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade 1, except alopecia and other events that are judged tolerable by the investigator;\n5. Has received treatment for the disease within 14 days before informed consent, including but not limited to cytotoxic therapy, monoclonal antibodies or ADCs, targeted therapy, radiotherapy, epigenetic therapy, or investigational agents, or invasive investigational medical devices within 14 days before informed consent. If the radiation field covers ≤ 5% of the bone marrow reserve, the participant is eligible regardless of the end date of radiotherapy;\n6. Systemic glucocorticoids equivalent to \\> 15 mg/day prednisone within 7 days prior to informed consent, with the exception of topical glucocorticoids;\n7. Vaccination with live attenuated vaccines, inactivate vaccines or RNA vaccines within 4 weeks prior to informed consent;\n8. Participants who are allergic or intolerant to preconditioning drugs, tocilizumab, or have other previous history of severe allergy such as anaphylactic shock;\n9. Patients with any heart disease in the 6 months prior to screening;\n10. Oxygen saturation \\< 92%,;\n11. Presence of a second primary malignancy requiring treatment or not in complete remission within the past 2 years;\n12. Major surgery within 2 weeks before informed consent or planned during the study period or within 4 weeks after giving study treatment (excluding local anesthesia such as cataract);\n13. Participants are unable or unwilling to comply with the requirements of the study protocol or are otherwise unsuitable for participating in this clinical study in the investigator 's assessment;"}, 'identificationModule': {'nctId': 'NCT06822868', 'acronym': 'CT1190B', 'briefTitle': 'A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Beijing GoBroad Hospital'}, 'officialTitle': 'A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell Therapy, in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': 'CT1190B-CG11001_04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAR-T cells（ chimeric antigen receptor T cells）', 'description': 'CT1190B cells infusion', 'interventionNames': ['Drug: CAR T cells']}], 'interventions': [{'name': 'CAR T cells', 'type': 'DRUG', 'description': 'chimeric antigen receptor T cells', 'armGroupLabels': ['CAR-T cells（ chimeric antigen receptor T cells）']}]}, 'contactsLocationsModule': {'locations': [{'zip': '102200', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kai Hu MD', 'role': 'CONTACT', 'email': 'huk@gobroadhealthcare.com', 'phone': '15010390336'}, {'name': 'Kai Hu MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing GoBroad Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Kai Hu MD', 'role': 'CONTACT', 'email': 'huk@gobroadhealthcare.com', 'phone': '15010390336'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kai Hu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kai Hu', 'investigatorAffiliation': 'Beijing GoBroad Hospital'}}}}