G-CSF injections are used to elevate monocyte counts in the peripheral blood of participants.
Mononuclear cells are collected from your body through apheresis.
As per the trial protocol, BM-1901 is given as a single dose on Days 1, 3, and 5.
"Patients will undergo regular follow-up visits, which include reviewing medical history, assessing treatment response, and conducting physical exams and blood tests."
"To join this study, patients must meet all the following requirements:
[1] Be between 18 and 75 years old, regardless of gender;
[2] Have a confirmed diagnosis of solid tumor with HER2-positive or low expression (local HER2 test results are acceptable): HER2-positive is defined as IHC 3+ or IHC 2+ with ISH+. HER2 low expression is defined as IHC 1+ or IHC 2+ with ISH-;
[3] Have experienced treatment failure or relapse after at least first- and second-line standard therapies, or be intolerant to or have voluntarily declined these treatments;
[4] Have an expected survival of more than 12 weeks;
[5] Have an ECOG performance status score of 0-2;
[6] Have at least one measurable lesion according to RECIST v1.1;
[7] Demonstrate normal function of major organs, as shown by:
Blood tests: HB ≥90 g/L, ANC ≥1.5 x 10^9/L, PLT ≥80 x 10^9/L, Alb ≥2.8 g/dL, serum lipase and amylase <1.5×ULN;
Biochemistry: TBIL ≤1.5 x ULN; ALT and AST ≤2.5 x ULN (≤5 x ULN if liver metastases are present); serum Cr ≤1 x ULN, creatinine clearance >50 mL/min (Cockcroft-Gault formula); left ventricular ejection fraction >55%; serum calcium, potassium, and magnesium levels within normal ranges;
[8] Have suitable veins for apheresis and no conditions that prevent cell separation;
[9] Women of childbearing potential must test negative for pregnancy. All participants must agree to use effective birth control from the time of consent until 1 year after the last dose of the study drug;
[10] Be able to tolerate G-CSF injections;
[11] Voluntarily agree to participate, sign the informed consent form, and commit to follow-up visits."
"Patients meeting any of the following criteria will not be eligible to participate in this study:
[1] A history of other cancers (excluding papillary thyroid cancer, skin cancer, or breast carcinoma in situ);
[2] Participation in another drug trial within the last 4 weeks;
[3] Chronic unhealed wounds or fractures in the chest or elsewhere;
[4] A history of substance abuse involving psychotropic drugs or an inability to quit, or a history of mental illness;
[5] Documented evidence of lung conditions such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced
pneumonitis, or severe lung dysfunction;
[6] Active infections requiring antibiotics, except for simple urinary tract infections or uncomplicated bacterial pharyngitis, as approved by the investigator;
[7] For patients with prior chemotherapy, hematologic toxicity of Grade 2 or higher, or non-hematologic toxicity of Grade 3 or higher, per NCI-CTCAE 4.0 at the time of enrollment;
[8] Known HIV infection, hepatitis B (HBsAg positive), or hepatitis C (anti-HCV positive with detectable viral load);
[9] Use of indwelling catheters or drainage tubes (e.g., bile drainage or pleural/peritoneal/pericardial catheters). Central venous catheters are permitted, while other devices (e.g., ostomy, nephrostomy tubes, or Foley catheters) will be assessed by the investigator for eligibility;
[10] Brain metastases, unless stable following radiotherapy or other treatments;
[11] A history of central nervous system (CNS) disorders, such as seizures, stroke, dementia, cerebellar disease, or autoimmune conditions affecting the CNS;
[12] Significant immune deficiency;
[13] A history of severe allergic reactions to key study medications (e.g., leukocyte-boosting agents, tocilizumab for cytokine release syndrome prevention, or anti-infective drugs);
[14] A history of deep vein thrombosis or pulmonary embolism within the last 6 months;
[15] Autoimmune diseases (e.g., Crohn’s disease, rheumatoid arthritis, or lupus) within the past 2 years that caused organ damage or required immunosuppressive therapy;
[16] Any condition that could compromise the safety or effectiveness of the study treatment;
[17] Other factors that, in the investigator’s judgment, make the patient unsuitable for the study."
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