Actively Recruiting
A Study of BL-M08D1 in Patients With Relapsed or Refractory Lymphoid Malignancies
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-01-21
22
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of BL-M08D1 in Patients With Relapsed or Refractory Lymphoid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agree to follow the study protocol
- Any gender
- Age between 18 and 75 years old
- Expected survival of at least 3 months
- Confirmed recurrent or refractory lymphoid malignancies with no standard treatment available
- Willing to provide tumor tissue samples from the past 2 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Previous treatment toxicity recovered to grade 1 or less
- No severe heart dysfunction with left ventricular ejection fraction of 50% or higher
- Adequate organ function
- Coagulation function within specified normal limits (INR ≤1.5, APTT ≤1.5 ULN)
- Urinary protein ≤ 2+ or ≤ 1000 mg/24h
- Negative pregnancy test for premenopausal women and agreement to use contraception during and 6 months after treatment
- Ability and willingness to comply with all study visits and procedures
You will not qualify if you...
- Received chemotherapy, biological therapy, or other anti-tumor treatments within 4 weeks or 5 half-lives before first dose
- Received palliative radiotherapy or anti-tumor traditional Chinese medicine within 2 weeks before first dose
- History of severe heart disease
- QT prolongation, complete left bundle branch block, or third-degree atrioventricular block
- Active autoimmune or inflammatory diseases
- Other cancers diagnosed within 5 years before first dose
- Poorly controlled hypertension despite two medications
- Poor glycemic control or diabetic gangrene
- History or current interstitial lung disease requiring steroids or grade 2 or higher radiation pneumonitis
- Severe respiratory impairment due to lung diseases
- Central nervous system involvement or disease
- Allergy to recombinant humanized or human-mouse chimeric antibodies or components of BL-M08D1
- Previous organ transplant or allogeneic hematopoietic stem cell transplantation
- Positive for HIV, active tuberculosis, or active hepatitis B or C infections
- Active infection requiring systemic treatment within 4 weeks before first dose
- Significant pleural, abdominal, pelvic, or pericardial effusion requiring drainage or symptoms within 4 weeks before first dose
- Participation in another drug trial within 4 weeks or 5 half-lives before first dose
- Pregnant or breastfeeding women
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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