Diffuse Large B-Cell LymphomaPhase 1/2NCT07818499
A Study of BL-M08D1 in Combination With Immunochemotherapy in Patients With Diffuse Large B-Cell Lymphoma
A Phase 1/2 study testing BL-M08D1, Rituximab and Gemcitabine Hydrochloride in people with Diffuse Large B-Cell Lymphoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This Phase Ib/II study is a clinical trial to explore the efficacy and safety of BL-M08D1 for injection in combination with immunochemotherapy in patients with diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- BL-M08D1, Rituximab and Gemcitabine Hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2026to Dec 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restriction;
- Age ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Patients with diffuse large B-cell lymphoma;
- Agree to provide archived tumor tissue specimens within 3 years or fresh tissue samples;
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- Must have at least one measurable lesion;
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
- No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
- Organ function levels must meet the requirements;
- Urine protein ≤1+ or <1000 mg/24h;
- For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must exclude pregnancy; patients must not be breastfeeding; all enrolled trial participants must take adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion;
- Trial participants must be able and willing to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.
Who cannot join
- Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
- History of severe heart disease or cerebrovascular disease within 6 months before screening;
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
- Active autoimmune diseases and inflammatory diseases;
- Diagnosis of active malignancy within 5 years prior to the first dose;
- Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
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- Hypertension inadequately controlled by antihypertensive medications;
- Trial participants with poorly controlled blood glucose;
- History of interstitial lung disease requiring corticosteroid therapy, or current ILD, or radiation pneumonitis of grade ≥2;
- Use of glucocorticoids at a dose >30 mg/day prednisone or equivalent, for purposes other than control of lymphoma symptoms;
- Concurrent pulmonary diseases resulting in clinically severe impairment of respiratory function;
- Patients with central nervous system involvement;
- Previous or current central nervous system disorders;
- Contraindications to any component of the study intervention, including but not limited to previous allergic reactions;
- Receipt of autologous hematopoietic stem cell transplantation or CAR-T cell therapy, etc., within 12 weeks prior to the first dose;
- Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;
- Pleural, abdominal, or pelvic effusion or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first study drug administration;
- Imaging findings indicating that the tumor has invaded or encased major blood vessels in the abdomen, chest, neck, pharynx, etc., or the pericardium or heart;
- Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;
- Pregnant or breastfeeding women;
- Other conditions that, in the investigator's opinion, make the participant unsuitable for enrollment in this clinical trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Qingqing Cai
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Depei Wu
About this study
Official title: A Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of BL-M08D1 for Injection in Combination With Immunochemotherapy in Patients With Diffuse Large B-Cell Lymphoma
This Phase Ib/II study is a clinical trial to explore the efficacy and safety of BL-M08D1 for injection in combination with immunochemotherapy in patients with diffuse large B-cell lymphoma.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- BL-M08D1, Rituximab, Gemcitabine Hydrochloride, Oxaliplatin, Cyclophosphamide
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-M08D1Drug
Administration by intravenous infusion for a cycle of 3 weeks.
RituximabDrug
Administration by intravenous infusion for a cycle of 3 weeks.
Administration by intravenous infusion for a cycle of 3 weeks.
OxaliplatinDrug
Administration by intravenous infusion for a cycle of 3 weeks.
CyclophosphamideDrug
Administration by intravenous infusion for a cycle of 3 weeks.
Doxorubicin Hydrochloride LiposomeDrug
Administration by intravenous infusion for a cycle of 3 weeks.
Administration by intravenous infusion for a cycle of 3 weeks.
Prednisone Acetate TabletsDrug
Oral administration for a cycle of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BL-M08D1+R-GemOx or BL-M08D1+R-CHOP | Experimental | Participants receive BL-M08D1+R-GemOx or BL-M08D1+R-CHOP for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. Receives: Drug: BL-M08D1; Drug: Rituximab; Drug: Gemcitabine Hydrochloride; Drug: Oxaliplatin; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride Liposome; Drug: Vincristine Sulfate; Drug: Prednisone Acetate Tablets |
| R-GemOx or R-CHOP | Active comparator | Participants receive R-GemOx or R-CHOP for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. Receives: Drug: Rituximab; Drug: Gemcitabine Hydrochloride; Drug: Oxaliplatin; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride Liposome; Drug: Vincristine Sulfate; Drug: Prednisone Acetate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase II Dose (RP2D)
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M08D1.
Measured: Up to approximately 24 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Measured: Up to approximately 24 months
Secondary outcomes (5)
Complete Remission Rate (CRR)
Complete Remission Rate (CRR) refers to the proportion of patients in a clinical trial who achieve a complete remission (CR) after receiving a specific treatment.
Measured: Up to approximately 24 months
Progression-free Survival (PFS)
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Measured: Up to approximately 24 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.
Measured: Up to approximately 24 months
Duration of Response (DOR)
Duration of Response (DOR) is defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
Measured: Up to approximately 24 months
Treatment-Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M08D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M08D1.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818499
- Sponsor's protocol ID
- BL-M08D1-201
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No