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.
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;
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;
Single group
BL-M11D1
DrugAdministration by intravenous infusion for a cycle of 4 weeks.
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.
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.
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.
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.
Cmax
Maximum serum concentration (Cmax) of BL-M11D1 will be investigated.
Tmax
Time to maximum serum concentration (Tmax) of BL-M11D1 will be investigated.
T1/2
Half-life (T1/2) of BL-M11D1 will be investigated.
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.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
