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RECRUITING
NCT06326021
PHASE1

Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia

Sponsor: Beijing GoBroad Hospital

View on ClinicalTrials.gov

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

DRUG

autologous FL-33 CAR T therapy

Autologous FL-33 CAR T cells are infused intravenously.

DRUG

prior-HSCT donor-derived FL-33 CAR T therapy

Prior-HSCT donor-derived FL-33 CAR T cells are infused intravenously.

DRUG

Newly matched donor-derived FL-33 CAR T therapy

Newly matched donor-derived FL-33 CAR T cells are infused intravenously

DRUG

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