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

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).

Conditions

• Refractory/Relapsed Acute Myeloid Leukaemia

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

Sponsors & Collaborators

• The General Hospital of Western Theater Command

  collaborator OTHER

• Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai

  collaborator OTHER

• Shanghai Liquan Hospital

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• Beijing GoBroad Hospital

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-02

Primary Completion

2026-06-15

Completion

2026-12-30

Countries

• China

Study Locations