protocolSection identificationModule nctId: NCT06343311, orgStudyIdInfo id: EBUS22CD19AR100, briefTitle: T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL), acronym: Starlight-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Estrella Biopharma, Inc., class: INDUSTRY, collaborators name: Eureka Therapeutics Inc., descriptionModule briefSummary: This is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study will include a dose escalation phase followed by an expansion phase., conditionsModule conditions: B-Cell Non-Hodgkin's Lymphoma (NHL), conditions: Lymphoma, Non-Hodgkins, conditions: Lymphomas Non-Hodgkin's B-Cell, conditions: Non-Hodgkin Lymphoma, conditions: Non-Hodgkin's Lymphoma, conditions: Large B-Cell Lymphoma, conditions: Lymphoma, Non-Hodgkin's, Adult, conditions: Lymphoma, conditions: Refractory Non-Hodgkin Lymphoma, conditions: Relapsed Non-Hodgkin Lymphoma, conditions: Lymphoma, Non-Hodgkin, conditions: HIV Associated Lymphoma, conditions: CNS Lymphoma, conditions: High-grade B-cell Lymphoma, conditions: Refractory B-Cell Non-Hodgkin Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: EB103, outcomesModule primaryOutcomes measure: To assess the Dose Limiting Toxicities of EB103., primaryOutcomes measure: Incidence rates of Treatment-Emergent Adverse Events of EB103., primaryOutcomes measure: Incidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103., primaryOutcomes measure: To determine the Recommended Phase II Dose (RP2D) of EB103., secondaryOutcomes measure: To assess the Overall Response Rate of EB103 in our study subject population., secondaryOutcomes measure: To assess the Disease Control Rate of EB103 in our study subject population., secondaryOutcomes measure: To assess the Duration of Response of EB103 in our study subject population., secondaryOutcomes measure: To assess the Progression-Free Survival rate of EB103 in our study subject population., secondaryOutcomes measure: To assess the Event-Free Survival rate of EB103 in our study subject population., secondaryOutcomes measure: To assess the Overall Survival rate of EB103 in our study subject population., secondaryOutcomes measure: To characterize the pharmacokinetic (PK) profile of EB103 by measuring the peak exposure (Cmax)., secondaryOutcomes measure: To characterize the pharmacokinetic (PK) profile of EB103 by measuring the time to reach peak exposure (Tmax)., secondaryOutcomes measure: To characterize the pharmacokinetic (PK) profile of EB103 by measuring the partial area under the curve (pAUC)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False