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| Name | Class |
|---|---|
| Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. | INDUSTRY |
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This study is an open, multicenter, non-randomized phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics characteristics and preliminary efficacy of BL-M24D1 in patients with relapsed or refractory multiple myeloma and other hematologic malignancies.
The study is divided into two phases: a dose escalation phase (Phase Ia) and an expansion cohort phase (Phase Ib).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BL-M24D1 | Experimental | Participants receive BL-M24D1 as intravenous infusion for the first cycle (2 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BL-M24D1 | Drug | Administration by intravenous infusion for a cycle of 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 28 days after the first dose |
| 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. | Up to 28 days after the first dose |
| 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-M24D1. | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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-M24D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M24D1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sa Xiao, PHD | Contact | 15013238943 | xiaosa@baili-pharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| Up to approximately 24 months |
| Cmax | Maximum serum concentration (Cmax) of BL-M24D1 will be investigated. | Up to approximately 24 months |
| Tmax | Time to maximum serum concentration (Tmax) of BL-M24D1 will be investigated. | Up to approximately 24 months |
| T1/2 | Half-life (T1/2) of BL-M24D1 will be investigated. | Up to approximately 24 months |
| 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. | Up to approximately 24 months |
| CL (Clearance) | CL in the serum of BL-M24D1 per unit of time will be investigated. | Up to approximately 24 months |
| Ctrough | Ctrough is defined as the lowest serum concentration of BL-M24D1 prior to the next dose will be administered. | Up to approximately 24 months |
| ADA (anti-drug antibody) | Frequency of anti-BL-M24D1 antibody (ADA) will be investigated. | Up to approximately 24 months |
| 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. | Up to approximately 24 months |
| 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. | Up to approximately 24 months |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |