Evaluating BL-M08D1 for patients with advanced lymphoid cancers

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Relapsed or Refractory Lymphoid Malignancies

This study is testing a new treatment called BL-M08D1 to see if it is safe and effective for people with advanced lymphoid cancers that haven't responded to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Chemotherapy, radiation
• Locations: 1 site (Harbin, Heilongjiang)
• Trial ID: NCT06718634 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter phase I study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M08D1 in patients with relapsed or refractory lymphoid malignancies. The study involves a dose-escalation approach to determine the optimal dosage while monitoring participants for adverse effects and treatment response. Eligible patients will receive BL-M08D1 injections and will be closely monitored throughout the trial to gather data on its effectiveness and safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with relapsed or refractory lymphoid malignancies that are incurable or lack standard treatment options.

Not a fit: Patients with severe cardiac dysfunction or those whose malignancies are not relapsed or refractory may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat lymphoid malignancies.

How similar studies have performed: While this approach is novel, similar studies targeting lymphoid malignancies have shown promise in evaluating new treatments.

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 \> 150 mmHg or diastolic blood pressure \> 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.

Where this trial is running

Harbin, Heilongjiang

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

Study contacts

• Study coordinator: Sa Xiao, PHD

Conditions Relapsed or Refractory Lymphoid Malignancies