a study of bl-m08d1 in patients with relapsed or refractory lymphoid malignancies

Conditions: Relapsed or Refractory Lymphoid Malignancies

Summary: this study is an open-label, multicenter, dose-escalation and extended-enrollment, nonrandomized phase i study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of bl-m08d1 for injection in relapsed or refractory lymphoid malignancies.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent form voluntarily and follow the protocol requirements; 2. gender is not limited; 3. age: ≥18 years old and ≤75 years old; 4. expected survival time ≥3 months; 5. recurrent or refractory lymphoid malignancies confirmed by histopathology and/or cytology that are incurable or for which no standard treatment is currently available; 6. consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years; 7. ecog≤2; 8. the toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by nci-ctcae v5.0; 9. no severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 10. organ function level must meet the requirements; 11. coagulation function: international normalized ratio (inr) ≤1.5, and activated partial thromboplastin time (aptt) ≤1.5uln; 12. urinary protein ≤2+ or ≤1000mg/24h; 13. for premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and the patient must not be lactating; all enrolled patients (regardless of male or female) should use adequate barrier contraception during the whole treatment cycle and for 6 months after the end of treatment; 14. subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures. exclusion criteria: 1. chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; palliative radiotherapy or traditional chinese medicine with anti-tumor indications within 2 weeks before the first dose; 2. history of severe heart disease; 3. qt prolongation, complete left bundle branch block, iii degree atrioventricular block; 4. active autoimmune and inflammatory diseases; 5. other malignant tumors diagnosed within 5 years before the first dose; 6. hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \&gt; 150 mmhg or diastolic blood pressure \&gt; 100 mmhg); 7. patients with poor glycemic control or with diabetic gangrene; 8. a history of ild requiring steroid therapy or current ild or grade ≥2 radiation pneumonitis; 9. complicated with pulmonary diseases leading to clinically severe respiratory function impairment; 10. patients with central nervous system involvement; 11. had a history of or central nervous system disease; 12. patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any component of bl-m08d1 excipients; 13. received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-hsct); 14. human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis b virus infection or active hepatitis c virus infection; 15. active infection requiring systemic therapy within 4 weeks before the first dose of study drug; 16. pleural, abdominal, pelvic or pericardial effusion requiring drainage and/or with symptoms within 4 weeks before the first dose of study drug; 17. received another trial drug 4 weeks or 5 half-lives before the first dose; 18. pregnant or lactating women; 19. other conditions for participation in the trial were not considered appropriate by the investigator.