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The goal of this clinical trial is to learn about the safety, tolerability and preliminary effectiveness of a treatment for patients with relapsed or refractory hematologic malignancies, regardless of gender, aged between 18(inclusive) and 70 years .
Participants will receive the investigational product intravenously every two or three weeks. The treatment will continue for a maximum of two years for those who do not show signs of disease progression or experience intolerable side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose escalation and expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT02 | Drug | BT02 monoclonal antibody injection with intravenous administration every 2 or 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Through the study completion, an average of 2.5 years | |
| Dose limited toxicity(DLT) | Through the dose escalation phase, an average of 10 months | |
| Maximum tolerable dose(MTD) | Through the dose escalation phase, an average of 10 months | |
| Recommended phase 2 dose(RP2D) | Through the study completion, an average of 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) on tumor assessments | Through the study completion, an average of 2.5 years | |
| Progression-free survival (PFS) on tumor assessments | Through the study completion, an average of 2.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical development director | Contact | +86-18602185973 | clin.oper@biotroy.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ying Wang, MD | Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS) | Principal Investigator |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D019337 | Hematologic Neoplasms |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
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| Overall survival (OS) | Through the study completion, an average of 2.5 years |
| Duration of response (DoR) on tumor assessments | Through the study completion, an average of 2.5 years |
| Disease control rate (DCR) on tumor assessments | Through the study completion, an average of 2.5years |
| Mean and median Area under the curve (AUC) of BT02 following first dose and repeated administration at each dose level | Through the study completion, an average of 2.5 years |
| Mean and median Maximum concentration (Cmax) of BT02 following first dose and repeated administration at each dose level | Through the study completion, an average of 2.5 years |
| ADA and NAb incidence | Through the study completion, an average of 2.5 years |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |