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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
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Title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
Protocol Number: SP071744 Study Stage: Phase I Study Number: 1 site Subject Number: up to 54 patients with Relapsed or Refractory B-cell Lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | A-319 dosage: 0.05, 0.15, 0.03, 0.06, 0.12, 0.18, 0.24 μg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Anti-CD19m-CD3 Antibody Injection | Biological | Intravenous Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Incidence and Characteristics of SAE of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | Incidence and Characteristics of SAE | At the end of Cycle 1 (each cycle is 28 days) |
| Evaluate the MTD and DLT of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | dose limited toxicity(DLT), maximum tolerance dose(MTD) | At the end of Cycle 1 (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the PK(Cmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | Peak Plasma Concentration(Cmax) | At the end of Cycle3 (each cycle is 28 days) |
| Evaluate the PK(AUC) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma |
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Inclusion Criteria:
Exclusion Criteria:• Past or present CNS disease
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Jing, Bachelor | Contact | 8613524953174 | yangj@generonbiomed.com |
| Name | Affiliation | Role |
|---|---|---|
| Song Yuqin, Doctor | Peking University Cancer Hospital & Institute | Principal Investigator |
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all IPD
After 20January2022(estimated), for 1years(estimated).
All.
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
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Area under the plasma concentration versus time curve(AUC)
| At the end of Cycle3 (each cycle is 28 days) |
| Evaluate the PK(Tmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | time to peak (Tmax) | At the end of Cycle3 (each cycle is 28 days) |
| Evaluate the PK(T1/2) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | half-life time(T1/2) | At the end of Cycle3 (each cycle is 28 days) |
| Evaluate the PK(CL) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | clearance(CL) | At the end of Cycle3 (each cycle is 28 days) |
| Evaluate the PK(Vz) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | volume of distribution(Vz) | At the end of Cycle3 (each cycle is 28 days) |
| Evaluate the PD of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | B-cell level | At the end of Cycle3 (each cycle is 28 days) |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |