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This is a single-arm, open-label, multicenter, dose-escalation, dose-expansion and efficacy-expansion phase I clinical study to evaluate the tolerability, safety, pharmacokinetics and preliminary antitumor activity of QLS2309 injection in patients with CD70+ relapsed/refractory hematologic malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS2309 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS2309 | Drug | initial dose - MTD; QW; intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity(DLT) | To evaluate the safety and tolerability of QLS2309 | 28 days |
| Recommended Phase Ib Dose (RPIbD) | The Safety Monitoring Committee (SMC) will select RP1bD based on the safety, tolerability, PK parameters, pharmacodynamics, preliminary effectiveness and other data of subjects in different dose groups | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojun Huang, MD | Contact | 01088316617 | xjhrm@medmail.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100032 | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |