RecruitingPhase 1NCT05924750
A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BL-M11D1 in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Enrollment
130 participants
Start Date
Aug 2, 2023
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria11
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restrictions;
- Age: ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Histologically and/or cytologically confirmed CD33-positive relapsed/refractory acute myeloid leukemia (AML);
- Morphological assessment showing ≥5% blasts in the bone marrow;
- ECOG performance status score ≤2;
- Peripheral blood white blood cell count ≤25×10\^9/L before the first dose;
- Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- Organ function levels meet the requirements within 7 days before the first dose;
- For premenopausal women with childbearing potential, a pregnancy test (serum/urine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients (regardless of gender) must use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.
Exclusion Criteria17
- Acute promyelocytic leukemia, acute transformation of chronic myeloid leukemia.
- 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.
- 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.
- Prolonged QT interval (QTc \> 450 msec in men or QTc \> 470 msec in women), complete left bundle branch block, and III degree atrioventricular block.
- 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).
- 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.
- Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg).
- Patients with pulmonary disease grade ≥3 defined by CTCAE v5.0, current or previous interstitial lung disease (ILD).
- Patients with central nervous system involvement.
- Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the ingredients of BL-M11D1.
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
- 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).
- Active infection requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.
- Presence of pleural, abdominal, pelvic or pericardial effusion with clinical symptoms or requiring repeated drainage.
- Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of last dose).
- Pregnant or lactating women.
- Other conditions for participation in the trial were not considered appropriate by the investigator.
Interventions
DRUGBL-M11D1
Administration by intravenous infusion
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT05924750