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RecruitingNCT06718634Updated Jan 21, 2026

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

A Phase 1 interventional study of BL-M08D1 in Relapsed or Refractory Lymphoid Malignancies, sponsored by Sichuan Baili Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Sichuan Baili Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Relapsed or Refractory Lymphoid Malignancies

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03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's planned enrollment of 22 is below the median of 50 across 3,374 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

Sichuan Baili Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 100 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • Experimental
    BL-M08D1

    Participants receive BL-M08D1 as intravenous infusion 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.

    Drug: BL-M08D1

Interventions

  • DrugBL-M08D1

    Administration by intravenous infusion for a cycle of 3 weeks.

06

What researchers measure

Primary outcomes

  1. Phase Ia: Dose limiting toxicity (DLT)

    DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.

    Time frame: Up to 21 days after the first dose

  2. Phase Ia: Maximum tolerated dose (MTD)

    MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle.

    Time frame: Up to 21 days after the first dose

  3. Phase Ib: 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.

    Time frame: Up to approximately 24 months

Secondary outcomes

  1. 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.

    Time frame: Up to approximately 24 months

  2. Cmax

    Maximum serum concentration (Cmax) of BL-M08D1 will be investigated.

    Time frame: Up to approximately 24 months

  3. Tmax

    Time to maximum serum concentration (Tmax) of BL-M08D1 will be investigated.

    Time frame: Up to approximately 24 months

  4. T1/2

    Half-life (T1/2) of BL-M08D1 will be investigated.

    Time frame: Up to approximately 24 months

  5. AUC0-t

    AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.

    Time frame: Up to approximately 24 months

  6. CL (Clearance)

    CL in the serum of BL-M08D1 per unit of time will be investigated.

    Time frame: Up to approximately 24 months

  7. Ctrough

    Ctrough is defined as the lowest serum concentration of BL-M08D1 prior to the next dose will be administered.

    Time frame: Up to approximately 24 months

  8. ADA (anti-drug antibody)

    Frequency of anti-BL-M08D1 antibody (ADA) will be investigated.

    Time frame: Up to approximately 24 months

  9. Phase Ib: 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.

    Time frame: Up to approximately 24 months

  10. Phase Ib: Disease Control Rate (DCR)

    The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]).

    Time frame: Up to approximately 24 months

  11. Phase Ib: Duration of Response (DOR)

    The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

    Time frame: Up to approximately 24 months

07

Study locations

1 of 1 sites recruiting
  • Harbin Medical University Cancer Hospital
    Harbin, Heilongjiang, China
    • Qingyuan Zhang · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06718634
Lead sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Dec 5, 2024
Start date
Jan 2, 2025
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jan 21, 2026

Study contacts

Sa Xiao, PHD
Contact
xiaosa@baili-pharm.com
15013238943

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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