A Study of BL-M08D1 in Patients With Relapsed or Refractory Lymphoid Malignancies

Recruiting now · Phase 1

Conditions studied: Relapsed or Refractory Lymphoid Malignancies

In brief

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.

Key facts

Study ID

NCT06718634

Run by

Sichuan Baili Pharmaceutical Co., Ltd.

People needed

22

Starts

2025-01-02

Expected to finish

2027-12-01

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Sign the informed consent form voluntarily and follow the protocol requirements;
• Gender is not limited;
• Age: ≥18 years old and ≤75 years old;
• Expected survival time ≥3 months;
• Recurrent or refractory lymphoid malignancies confirmed by histopathology and/or cytology that are incurable or for which no standard treatment is currently available;
• Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years;
• ECOG≤2;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• Organ function level must meet the requirements;
• Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
• Urinary protein ≤2+ or ≤1000mg/24h;
• 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;
• Subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.

You may not qualify if…

• 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;
• History of severe heart disease;
• QT prolongation, complete left bundle branch block, III degree atrioventricular block;
• Active autoimmune and inflammatory diseases;
• Other malignant tumors diagnosed within 5 years before the first dose;
• Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
• Patients with poor glycemic control or with diabetic gangrene;
• A history of ILD requiring steroid therapy or current ILD or grade ≥2 radiation pneumonitis;
• Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
• Patients with central nervous system involvement;
• Had a history of or central nervous system disease;
• Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any component of BL-M08D1 excipients;
• Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
• Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
• Active infection requiring systemic therapy within 4 weeks before the first dose of study drug;
• Pleural, abdominal, pelvic or pericardial effusion requiring drainage and/or with symptoms within 4 weeks before the first dose of study drug;
• Received another trial drug 4 weeks or 5 half-lives before the first dose;
• Pregnant or lactating women;
• Other conditions for participation in the trial were not considered appropriate by the investigator.

Where it is running

• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (enrolling)

Full record on ClinicalTrials.gov

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