Actively Recruiting
Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia
Led by Beijing GoBroad Hospital · Updated on 2026-03-10
27
Participants Needed
4
Research Sites
143 weeks
Total Duration
On this page
Sponsors
B
Beijing GoBroad Hospital
Lead Sponsor
T
The General Hospital of Western Theater Command
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary resistant acute myeloid leukemia or relapsed/refractory disease after chemotherapy or allogeneic stem cell transplantation
- Tumor cells positive for CD33 by flow cytometry or immunohistochemistry
- Age between 1 and 70 years
- No severe allergies
- Physical condition with ECOG score between 0 and 2
- Expected survival of at least 60 days
- Patients aged 19 to 70 years able to sign informed consent; for ages 1 to 7 years, legal guardian consent required; ages 8 to 18 years require both patient and guardian consent
- Suitable and available allogeneic stem cell transplant donors if transplantation is planned after CAR T treatment
You will not qualify if you...
- Lack of peripheral blood mononuclear cells from prior transplant donor if history of allogeneic HSCT and peripheral blood tumor load over 30%
- Peripheral blood tumor load over 30% without prior allogeneic HSCT
- Intracranial hypertension or impaired consciousness
- Symptomatic heart failure or severe arrhythmia
- Severe respiratory failure symptoms
- Presence of other malignancies
- Diffuse intravascular coagulation
- Serum creatinine or urea nitrogen levels 1.5 times above normal
- Sepsis or uncontrollable infection
- Uncontrolled diabetes mellitus
- Severe mental disorders
- Significant intracranial lesions on MRI
- History of organ transplantation other than hematopoietic stem cell transplantation
- Female patients of childbearing potential with positive blood HCG test
- Hepatitis B or C infection and positive screening for AIDS or syphilis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai
Shanghai, Shanghai Municipality, China, 200435
Not Yet Recruiting
2
Shanghai Liquan Hospital
Shanghai, Shanghai Municipality, China, 201418
Not Yet Recruiting
3
The General Hospital of Western Theater Command PLA
Chengdu, Sichuan, China, 610083
Not Yet Recruiting
4
BeijingGoBroadH
Beijing, China
Actively Recruiting
Research Team
S
Shaocong Miao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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