protocolSection identificationModule nctId: NCT06377228, orgStudyIdInfo id: TAK-007-1001, briefTitle: A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-01, primaryCompletionDateStruct date: 2029-04-23, completionDateStruct date: 2029-04-23, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Takeda, class: INDUSTRY, descriptionModule briefSummary: The main aim of the study is to learn how well adults with refractory lupus nephritis (LN) tolerate TAK-007 and to check for side effects (adverse events).Other aims are to learn how effective treatment with TAK-007 is in adults with refractory LN, what effects TAK-007 has on the human body, and whether participants will produce antibodies against TAK-007., conditionsModule conditions: Refractory Lupus Nephritis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: TAK-007, interventions name: Chemotherapy Agents, outcomesModule primaryOutcomes measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), primaryOutcomes measure: Number of Participants With Dose Limiting Toxicities (DLTs), secondaryOutcomes measure: Cmax: Maximum Observed Plasma Concentration for TAK-007, secondaryOutcomes measure: Tmax: Time to Reach the Cmax for TAK-007, secondaryOutcomes measure: Tlast: Time of Last Measurable Concentration Above the Lower Limit of Quantitation for TAK-007, secondaryOutcomes measure: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-007, secondaryOutcomes measure: Change From Baseline in CD19+ B Cell Counts, secondaryOutcomes measure: Duration of B Cell Depletion, secondaryOutcomes measure: Change From Baseline in Plasma Cytokine Levels, secondaryOutcomes measure: Change From Baseline in Physician's Global Assessment (PGA) Score, secondaryOutcomes measure: Percentage of Participants Achieving a Reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Relative to Baseline, secondaryOutcomes measure: Percentage of Participants Achieving Complete Renal Response (CRR), secondaryOutcomes measure: Time to CRR, secondaryOutcomes measure: Duration of CRR, secondaryOutcomes measure: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS), secondaryOutcomes measure: Time to LLDAS, secondaryOutcomes measure: Duration of LLDAS, secondaryOutcomes measure: Percentage of Participants Meeting the Definition of Remission in SLE (DORIS) Criteria, secondaryOutcomes measure: Time to DORIS Remission, secondaryOutcomes measure: Duration of DORIS Remission, secondaryOutcomes measure: Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (dsDNA) Levels, secondaryOutcomes measure: Change From Baseline in Antinuclear Antibody (ANA) Levels, secondaryOutcomes measure: Change From Baseline in Proteinuria Levels, secondaryOutcomes measure: Change From Baseline in Creatinine Levels, secondaryOutcomes measure: Change From Baseline in eGFR, secondaryOutcomes measure: Change From Baseline in Complement (C3, C4) Levels, secondaryOutcomes measure: Percentage of Participants With Antidrug Antibodies Categorized as Anti-Human Leukocyte Antigen (HLA) and Anti- Chimeric Antigen Receptor (CAR), secondaryOutcomes measure: Percentage of Participants With Replication Competent Retrovirus (RCR) in Blood, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Site Contact, role: CONTACT, phone: 888-229-3065, email: madisonj@med.umich.edu, contacts name: Jacqueline Madison, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, locations facility: University of Rochester, city: Rochester, state: New York, zip: 14642, country: United States, contacts name: Site Contact, role: CONTACT, phone: 585-486-0901, email: christopher_palma@urmc.rochester.edu, contacts name: Christopher Palma, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.15478, lon: -77.61556, locations facility: UT Health Houston, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Site Contact, role: CONTACT, phone: 713-486-3100, email: Meera.g.subash@uth.tmc.edu, contacts name: Meera Subash, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False