protocolSection identificationModule nctId: NCT06326021, orgStudyIdInfo id: BJGBYY-IIT-LCYJ-2024-004, briefTitle: Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2026-06-15, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Beijing GoBroad Hospital, class: OTHER, descriptionModule briefSummary: This study is a single-center, open-label, non-randomised, single-arm phaseⅠclinical trial to explore the safety and efficacy of FL-33 CAR T therapy for refractory/relapsed acute myeloid leukaemia. The primary endpoints are incidence and type of dose limiting toxicity within 21 days of CAR T infusion; total number, incidence and severity of adverse events (AE) 30 days after CAR T infusion. The secondary endpoints are total number, incidence and severity of AEs 30 days to 2 years after CAR T infusion; objective response rate (ORR), complete response rate (CR) and complete response with incomplete haematological recovery (CRi) by dose group at 15, 30 and 90 Days after CAR T Infusion; duration of response (DOR), progression-free survival (PFS), overall survival (OS); pharmacokinetic characteristics. The trial will use BOIN12 design to explore the optimal biological dose (OBD) of FL-33 CAR T cells for refractory/relapsed acute myeloid leukaemia. FL-33 CAR T is set at two dose levels: 5\*10\^5 (±20%) CAR-T cells/kg for dose 1 (DL-1) and 1\*10\^6 (±20%) CAR-T cells/kg for dose 2 (DL-2), and after the optimal biological dose (OBD) is determined in the dose exploration phase, the dose expansion phase will expand the trial by 6-12 cases at the OBD, enrolling up to 21-27 cases. Enrolment of more than 21 cases can be reported for analysis and the trial will be stopped when enrolment reaches 27 cases., conditionsModule conditions: Refractory/Relapsed Acute Myeloid Leukaemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: autologous FL-33 CAR T therapy, interventions name: prior-HSCT donor-derived FL-33 CAR T therapy, outcomesModule primaryOutcomes measure: Dose-limiting toxicity(DLT), primaryOutcomes measure: Adverse events (AEs), secondaryOutcomes measure: Long-term Adverse events (AEs), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: The persistence of FL-33 CAR T cells, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: BeijingGoBroadH, status: RECRUITING, city: Beijing, country: China, contacts name: Tengyu Wang, role: CONTACT, phone: 18333186020, email: tengyu.wang@gohealtharo.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False