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Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia
Sponsor: Beijing GoBroad Hospital
Summary
This study is a multi-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.Additionally, an independent observation group was established, comprising two sequential cohorts: a minimum of 3 subjects were enrolled starting from the lowest dose level (DL-1).
Official title: Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia:a Multi-center, Open-label, Non-randomised, Single-arm Phase Ⅰ Clinical Trial
Key Details
Gender
All
Age Range
1 Year - 70 Years
Study Type
INTERVENTIONAL
Enrollment
27
Start Date
2024-04-02
Completion Date
2026-12-30
Last Updated
2026-03-10
Healthy Volunteers
No
Interventions
autologous FL-33 CAR T therapy
Autologous FL-33 CAR T cells are infused intravenously.
prior-HSCT donor-derived FL-33 CAR T therapy
Prior-HSCT donor-derived FL-33 CAR T cells are infused intravenously.
Newly matched donor-derived FL-33 CAR T therapy
Newly matched donor-derived FL-33 CAR T cells are infused intravenously
FL33-03 CAR-T therapy
Optimized FL-33-03 CAR-T cells
Locations (4)
Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai
Shanghai, Shanghai Municipality, China
Shanghai Liquan Hospital
Shanghai, Shanghai Municipality, China
The General Hospital of Western Theater Command PLA
Chengdu, Sichuan, China
BeijingGoBroadH
Beijing, China