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The study is terminated due to major protocol revisions.
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| Name | Class |
|---|---|
| Shenzhen MingSight Relin Pharmaceutical Co., Ltd | UNKNOWN |
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This is a Phase I/II, single-arm, multicenter, open-label study which is divided into two portions: Phase I is dose escalation portion, in which subjects with relapsed or refractory B-cell lymphoma will be enrolled except malignant lymphoblastic lymphoma (LBL) and Burkitt lymphoma. After the RP2D is identified, Phase II of subjects with relapsed or refractory mantle cell lymphoma who previously received ≥ 2 and ≤ 4 different chemotherapy and/or targeted drug therapy will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | dose exploration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MS-553 | Drug | MS-553 oral tablet BID x 28-days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicity (DLT) | First cycle (28 days) | |
| Incidence and severity of adverse events | up to 24 months | |
| To determine the MTD and RP2D of oral MS-553 in patients with BCL | about 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | up to 24 months | |
| Duration of response (DOR) | up to 24 months | |
| progression-free survival (PFS) |
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Inclusion Criteria:
1) Patients in Phase I study will be enrolled with refractory or relapsed B-cell non-Hodgkin lymphoma.
2) Patients enrolled in the phase I study failed two or more lines of treatment regimens; Patients with mantle cell lymphoma should also be patients with contraindications or failure of BTK inhibitor therapy.
3) Eastern Cooperative Oncology Group (ECOG) performance status score is 0~2.
4) Have life expectancy ≥ 3 months.
5) Major organ functions meet the following criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | China |
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| up to 24 months |
| overall survival (OS) | up to 24 months |
| time to progression (TTR) | up to 24 months |
| disease control rate (DCR) | up to 24 months |
| Pharmacokinetics parameters: Cmax | within the first 2 cycles (56 days) |
| Pharmacokinetics parameters: Tmax | within the first 2 cycles (56 days) |
| Pharmacokinetics parameters: T1/2 | within the first 2 cycles (56 days) |
| Pharmacokinetics parameters: AUC0-12 | within the first 2 cycles (56 days) |
| Pharmacokinetics parameters: CL/F | within the first 2 cycles (56 days) |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016393 | Lymphoma, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| 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 |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
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