Evaluating BL-M08D1 for patients with advanced lymphoid cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Recruiting

Study contacts

• Study coordinator: Sa Xiao, PHD
• Email: xiaosa@baili-pharm.com
• Phone: 15013238943

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BL-M08D treatment in melanoma and other solid tumors

  A phase Ib/II study tests BL-M08D1 injections in adults with locally advanced or metastatic melanoma and other solid tumors to see if it is safe and helpful.

  Recruiting Phase 1/2 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07841925

• BL-M08D in patients with digestive tract and other solid tumors

  A early-stage study to see if BL-M08D1 can be safely given and help people with advanced digestive tract cancers and other solid tumors.

  Recruiting Phase 1/2 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07780318

• BL-ARC002 in patients with advanced solid tumors

  This study tests BL-ARC002 to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors.

  Recruiting Phase 1 Sichuan Baili Pharmaceutical Co., Ltd. · Guangzhou, Guangdong · NCT07763652

• SI-B036 in head and neck and other solid tumors: a first-in-human study

  This early-phase study tests SI-B036 in adults with locally advanced or metastatic head and neck cancers and other solid tumors to see if it is safe and tolerable, and to get initial clues about its activity.

  Recruiting at 2 sites Phase 1 Sichuan Baili Pharmaceutical Co., Ltd. · Changsha, Hunan and 1 other locations · NCT07763639

• SI-B036 in locally advanced or metastatic breast cancer and other solid tumors

  Scientists are testing SI-B036 to see if it is safe and tolerable in adults with advanced breast cancer or other solid tumors and to get early signals of whether it might help.

  Recruiting Phase 1 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07753226

• BL-B01D1 plus PD-1 therapy vs nab-paclitaxel plus PD-1 therapy in untreated PD-L1-positive locally advanced or metastatic TNBC

  This phase 3 trial tests whether BL-B01D1 with a PD-1 antibody works better than nab-paclitaxel with a PD-1 antibody in women with newly treated, PD-L1-positive, locally advanced or metastatic triple-negative breast cancer.

  Recruiting Phase 3 Sichuan Baili Pharmaceutical Co., Ltd. · Shanghai, Shanghai Municipality · NCT07729956

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.