A Study of BL-M11D1 in Patients With Relapsed/Refractory Myelodysplastic Syndromes

NCT07591168 | Not Yet Recruiting Phase 1

• 1 other identifier: BL-M11D1-102
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, multicenter, non-randomized Phase Ib/II clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of BL-M11D1 for injection in patients with relapsed/refractory myelodysplastic syndromes.

Conditions

Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (4)

• 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-M11D1.

  Up to approximately 24 months

• Phase Ib: 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-M11D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M11D1.

  Up to approximately 24 months

• Phase II: 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.

  Up to approximately 24 months

• Phase II: Complete Response (CR)

  Complete Response (CR) is defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) having a short axis diameter reduced to \<10 mm.

  Up to approximately 24 months

Secondary Outcomes (10)

• Cmax

  Up to approximately 24 months

• Tmax

  Up to approximately 24 months

• T1/2

  Up to approximately 24 months

• AUC0-t

  Up to approximately 24 months

• CL (Clearance)

  Up to approximately 24 months

Study Arms (1)

BL-M11D1

EXPERIMENTAL

Participants receive BL-M11D1 for the first cycle (4 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-M11D1

Interventions

BL-M11D1 DRUG

Administration by intravenous infusion for a cycle of 4 weeks.

BL-M11D1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• No gender restrictions;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Relapsed/refractory CD33+ MDS;
• Morphological assessment showing blasts in bone marrow ≥5% and \<20%;
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
• Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
• Meet the required organ function levels;
• For premenopausal women of childbearing potential, a pregnancy test (serum/urine) must be negative within 7 days before starting treatment, and they must not be breastfeeding; all enrolled trial participants (regardless of gender) must practice adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion.

You may not qualify if:

• Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
• Presence of uncorrected folate deficiency or vitamin B12 deficiency, etc.;
• History of severe cardiovascular or cerebrovascular disease;
• Thromboembolic events requiring therapeutic intervention within 6 months prior to screening;
• Active autoimmune diseases and inflammatory diseases;
• History of extensive bowel resection or presence of Crohn's disease, ulcerative colitis, chronic diarrhea, or intestinal obstruction;
• Diagnosis of another malignancy within 5 years prior to the first dose;
• Poorly controlled hypertension;
• Poorly controlled hyperglycemia or diabetes mellitus;
• Pulmonary diseases classified as Grade ≥3 according to CTCAE v6.0, etc.;
• Trial participants with central nervous system involvement;
• Trial participants with extramedullary involvement;
• Trial participants with a history of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or hypersensitivity to any excipient component of BL-M11D1;
• Prior organ transplantation or hematopoietic stem cell transplantation;
• Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

CN (1)