protocolSection identificationModule nctId: NCT06318884, orgStudyIdInfo id: SCTB35-X101, briefTitle: A First-in-human Study of SCTB35 in Patients With Relapse/Refractory B-cell Non-Hodgkin Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Sinocelltech Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a Phase I clinical study designed to evaluate the safety, tolerability, and pharmacokinetics, and preliminary efficacy of SCTB35 monotherapy, an bispecific antibody, in patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma., conditionsModule conditions: Non-Hodgkin Lymphoma, B-cell, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: SCTB35 injection, outcomesModule primaryOutcomes measure: Dose-escalation part: dose limited toxicity (DLT), primaryOutcomes measure: Dose-escalation part: incidence rate of adverse event (AE), primaryOutcomes measure: Dose-expansion part: objective response rate (ORR), secondaryOutcomes measure: Dose-escalation part: ORR, secondaryOutcomes measure: Dose-escalation part: CR rate (CRR), secondaryOutcomes measure: Dose-escalation part: best of overall response (BOR), secondaryOutcomes measure: Dose-escalation part: duration of response (DOR), secondaryOutcomes measure: Dose-escalation part: progression-free survival (PFS), secondaryOutcomes measure: Dose-escalation part: time to response (TTR), secondaryOutcomes measure: Dose-escalation part: overall survival (OS), secondaryOutcomes measure: Dose-escalation part: blood concentrations of SCTB35, secondaryOutcomes measure: Dose-escalation part: anti-drug antibodies of SCTB35, secondaryOutcomes measure: Dose-expansion part: CRR, secondaryOutcomes measure: Dose-expansion part: BOR, secondaryOutcomes measure: Dose-expansion part: DOR, secondaryOutcomes measure: Dose-expansion part: PFS, secondaryOutcomes measure: Dose-expansion part: TTR, secondaryOutcomes measure: Dose-expansion part: OS, secondaryOutcomes measure: Dose-expansion part: AE, secondaryOutcomes measure: Dose-expansion part: blood concentrations of SCTB35, secondaryOutcomes measure: Dose-expansion part: anti-drug antibodies of SCTB35, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Yuqin Song, M.D., role: CONTACT, phone: 010-88196118, email: SongYQ_VIP@163.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Henan Cancer Hospital, city: Zhengzhou, state: Henan, country: China, contacts name: Keshu Zhou, M.D., role: CONTACT, phone: 13674902391, email: dr_zkshu23810@163.com, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Tianjin Medical University Cancer Institute & Hospital, city: Tianjin, state: Tianjin, zip: 300060, country: China, contacts name: Lanfang Li, M.D., role: CONTACT, phone: 18622221613, email: lilanfangmeng@163.com, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False