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

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT07591168
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BL-M11D1 — DRUG
    Administration by intravenous infusion for a cycle of 4 weeks.

Study Details

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.

Key Dates

First listed
May 15, 2026
Start date
May 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
92 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BL-M11D1
    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.

Primary Outcome Measure

Phase Ib: Recommended Phase II Dose (RP2D) [ Time Frame: Up to approximately 24 months ]

Central Contacts

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