FL-33 CAR T cells for hard-to-treat or returning acute myeloid leukaemia
Tests FL-33 CAR T therapy in hard-to-treat acute myeloid leukaemia.
Plain-language title generated from the registry record
Registry title: Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia
Key facts
- Where
- Beijing, Chengdu, and Shanghai, ChinaSee the 4 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 1 to 70 with acute myeloid leukaemia that did not respond to treatment or came back, and whose leukaemia cells carry the CD33 marker. They would receive FL-33 CAR T cell therapy.
- Age
- 1 to 70 years
- Sex
- All sexes
- Disease stage
- Acute myeloid leukaemia that resisted first treatment, came back after chemotherapy, came back outside the bone marrow, still shows leftover disease, or came back after a donor stem cell transplant. Fit for daily activity (ECOG score 0-2) and expected to live at least 60 days.
- Earlier treatment
- A donor stem cell transplant is allowed but not required. A suitable and available donor is needed so that a donor stem cell transplant can be done after FL-33 CAR T treatment.
- Biomarker or test result
- Leukaemia cells in bone marrow or spinal fluid must be positive for CD33 by flow cytometry, or tumour tissue positive for CD33 by immunohistochemistry.
Main reasons for not taking part
- Leukaemia cells in the blood above 30%
- Another type of cancer
- Heart failure with symptoms, severe breathing failure, or raised pressure in the skull
- Sepsis or an infection that cannot be controlled
- Hepatitis B or C, HIV or syphilis
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 70 years old?
Source: NCT06326021, who can take part
Where in China
- BeijingGoBroadHBeijing, ChinaContact: ZeLing WangTaking people
- The General Hospital of Western Theater Command PLAChengdu, ChinaContact: Shaocong MiaoNot yet recruiting
- Shanghai Liquan HospitalShanghai, ChinaContact: Shaocong MiaoNot yet recruiting
- Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, ShanghaiShanghai, ChinaContact: Shaocong MiaoNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Beijing GoBroad Hospital
- Trial code
- NCT06326021
- Record updated
- 22 May 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: Patients who met all the inclusion criteria were eligible for enrolment; Patients diagnosed with primary resistance acute myeloid leukemia, tumour surface antigen CD33 expression, chemotherapy relapse, extramedullary relapse, persistent residual positivity or relapse/refractory after allogeneic haematopoietic stem cell transplantation; Age 1-70 years old; No severe allergies; Physical condition: 0-2 ECOG score; Expected survival ≥ 60 days; Bone marrow or cerebrospinal fluid tumour cells are positive for CD33 by flow cytometry assay or tumour tissues positive for CD33 by immunohistochemistry (CD33 determination of positivity: flow cytometry: >80% of tumour cells expressing CD33 and MFI similar to normal myeloid cells is considered as full positivity; tumour cells greater than 80% of expression of CD33 but MFI lower than the CD33 expression of normal myeloid cells by 1 log is considered as low expression (dim). Tumour cells with between 20-80% positive CD33 expression are partially expressed; Pathological immunohistochemistry: tumour cells>30% positive are considered to be positively expressed; Self-aware patients aged 19-70 years are required to voluntarily sign an informed consent form in writing; paediatric patients aged 1-7 years can be recruited after their legal representative (guardian) had signed an informed consent form; self-aware paediatric patients aged 8-18 years voluntarily sign an informed consent form in writing, and their legal representative (guardian) are required to sign an informed consent form in writing as well; Suitable and available allogeneic haematopoietic stem cell transplant donors are required, and allogeneic haematopoietic stem cell transplantation can be performed after receiving FL-33 CAR T treatment.
Exclusion: Patients who fulfil any of the following criteria may not be enrolled; Patients with history of allogeneic HSCT but PBMNC is not available from prior- transplant donor for preparation of CAR T cells and peripheral blood tumour load >30%; patients without history of allogeneic HSCT and peripheral blood tumour load >30%; Intracranial hypertension or cerebral impaired consciousness; Symptomatic heart failure or severe arrhythmia; Symptoms of severe respiratory failure; With other types of malignancy; Diffuse intravascular coagulation; Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value; With sepsis or other uncontrollable infection; Suffering from uncontrollable diabetes mellitus; Severe mental disorders; Have significant intracranial lesions on cranial MRI; Organ transplantation (excluding haematopoietic stem cell transplantation) history; Female patients (patients of childbearing potential) with positive blood HCG test; Hepatitis (including hepatitis B and C) and positive screening for AIDS and syphilis.