Trial Title:
A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT ID:
NCT05924750
Condition:
Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BL-M11D1
Description:
Administration by intravenous infusion
Arm group label:
Study treatment
Summary:
Ia: To observe the safety and tolerability of BL-M11D1 in patients with
relapsed/refractory acute myeloid leukemia to determine the maximum tolerated dose (MTD)
and dose-limiting toxicity (DLT) of BL-M11D1. Ib: Further observe the safety and
tolerability of BL-M11D1 at the recommended dose in phase Ia to determine the recommended
dose in phase II clinical study (RP2D).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily sign the informed consent and follow the requirements of the protocol.
2. No gender limit.
3. Age: ≥18 years old and ≤75 years old.
4. expected survival time ≥3 months.
5. Relapsed/refractory acute myeloid leukemia (AML) confirmed by histopathology and/or
cytology;Patients who met the following criteria were defined as relapsed/refractory
AML, including: newly diagnosed patients who failed to respond to 2 courses of
standard regimens; Patients who relapsed within 12 months after complete remission
after consolidation and intensive therapy; Patients relapsed after 12 months but
failed to respond to conventional chemotherapy; Patients with two or more
recurrences; Patients with persistent extramedullary leukemia and bone marrow blasts
≥5%; Investigator-assessed patients with relapsed or refractory acute myeloid
leukemia who were not or were ineligible for/intolerant of other therapies.
6. ECOG ≤2.
7. Toxicity of previous antineoplastic therapy has returned to grade 1 or less as
defined by NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities
considered by the investigator, such as elevated alkaline phosphatase,
hyperuricemia, elevated serum amylase/lipase, and elevated blood glucose; The
exception was toxicity that was judged by the investigator to be not a safety risk,
such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism that was
stable with hormone replacement therapy).
8. The level of organ function within 7 days before the first dose meets the following
requirements and meets the following criteria:
1. Liver function: Total bilirubin ≤1.5 ULN (Gilbert's syndrome ≤3 ULN),
transaminase (AST/ALT) ≤2.5 ULN (subjects with liver tumor invasive changes
≤5.0 ULN), and/or alkaline phosphatase ≤5 ULN without correction with
liver-protective drugs within 7 days before screening;
2. renal function: creatinine (Cr) ≤1.5 ULN or creatinine clearance (Ccr) ≥50
mL/min (according to the center's calculation criteria);
3. coagulation function: international normalized ratio (INR) ≤1.5 and activated
partial thromboplastin time (APTT) ≤1.5ULN;
4. proteinuria ≤2+ or ≤1000mg/24h.
9. For premenopausal women with childbearing potential, pregnancy tests must be
performed within 7 days before starting treatment, serum/urine pregnancy must be
negative, and must be non-lactating; All enrolled patients (male or female) were
advised to use adequate barrier contraception throughout the treatment cycle and for
6 months after the end of treatment.
Exclusion Criteria:
1. Acute promyelocytic leukemia, acute transformation of chronic myeloid leukemia.
2. Antineoplastic therapy, including chemotherapy, biologic therapy, immunotherapy,
definitive radiotherapy, major surgery (investigator-defined), or targeted therapy
(including small-molecule tyrosine kinase inhibitors), has been administered within
4 weeks or 5 half-life cycles (whichever is shorter) before the first dose; Or
palliative radiotherapy within 2 weeks before the first dose.
3. History of severe heart disease, such as left ventricular ejection fraction < 50%,
history of symptomatic congestive heart failure (CHF) ≥ grade 2 (CTCAE v5.0), New
York Heart Association (NYHA) ≥ grade 2 heart failure, history of myocardial
infarction, unstable angina, etc.
4. Prolonged QT interval (QTc > 450 msec in men or QTc > 470 msec in women), complete
left bundle branch block, and III degree atrioventricular block.
5. Active autoimmune diseases and inflammatory diseases, such as systemic lupus
erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis,
inflammatory intestinal diseases and Hashimoto's thyroiditis, etc., excluding type I
diabetes mellitus, hypothyroidism that can only be controlled by replacement
therapy, and skin diseases without systemic treatment (such as vitiligo and
psoriasis).
6. Other malignancies diagnosed within 5 years before the first dose, except for
radical basal cell carcinoma, squamous cell carcinoma, and/or radical resection
carcinoma in situ.
7. Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic
blood pressure > 100 mmHg).
8. Patients with pulmonary disease grade ≥3 defined by CTCAE v5.0, current or previous
interstitial lung disease (ILD).
9. Patients with central nervous system involvement.
10. Patients with a history of allergy to recombinant humanized antibody or human-mouse
chimeric antibody or to any of the ingredients of BL-M11D1.
11. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation
(Allo-HSCT).
12. Human immunodeficiency virus (HIVAb) positive, active tuberculosis, active hepatitis
B virus infection (HBsAg positive; HBcAb positive and HBV-DNA copy number > lower
detection limit) or active hepatitis C virus infection (HCV antibody positive and
HCV-RNA > lower detection limit).
13. Active infection requiring systemic treatment, such as severe pneumonia, bacteremia,
sepsis, etc.
14. Presence of pleural, abdominal, pelvic or pericardial effusion with clinical
symptoms or requiring repeated drainage.
15. Had participated in another clinical trial within 4 weeks before the first dose
(calculated from the time of last dose).
16. Pregnant or lactating women.
17. Other conditions for participation in the trial were not considered appropriate by
the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Changcheng Zheng
Facility:
Name:
Beijing Hospital
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hui Liu
Facility:
Name:
Institute of Hematology, the First Hospital of Harbin
Address:
City:
Haerbin
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Tiejun Gong
Facility:
Name:
Shengjing Hospital of China Medical University
Address:
City:
Shenyang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhuogang Liu
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Chunyan Ji
Investigator:
Last name:
Chunyan Ji
Email:
Principal Investigator
Investigator:
Last name:
Jingjing Ye
Email:
Principal Investigator
Facility:
Name:
Shanghai Tongji Hospital
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ping Li
Facility:
Name:
West China Hospital，Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yu Wu
Facility:
Name:
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Yali Zhang
Phone:
022-23909095
Email:
ec@ihcams.ac.cn
Investigator:
Last name:
Junyuan Qi
Email:
Principal Investigator
Investigator:
Last name:
Jianxiang Wang
Email:
Principal Investigator
Start date:
August 2, 2023
Completion date:
August 2025
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Baili Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05924750
