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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • BL-M11D1

Treatment groups

92 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator