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This study is an open-label, dose-escalation and efficacy-expansion Phase I clinical trial to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary antitumor activity of QLS2313 as a monotherapy in patients with relapsed/refractory hematological malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS2313 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS2313 | Drug | CD79b/CD3/CD20;first in human; subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT, MTD, RPIbD, and RP2D | To evaluate the tolerability and safety of subcutaneously administered QLS2313 for Injection in patients with hematological malignancies, and to determine the MTD, RPIbD, and RP2D. | to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao, PhD | Contact | 15214370575 | zwl_trial@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiaotong University School of Medicine Ruijin Hospital | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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