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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05720052
Other study ID # 2020-003-CN
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date February 6, 2023
Est. completion date July 5, 2026

Study information

Verified date February 2023
Source MingSight Pharmaceuticals, Inc
Contact Ling Yang
Phone 8613421382136
Email yangling@relin.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 38
Est. completion date July 5, 2026
Est. primary completion date April 4, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: - In the absence of growth factor support therapy or blood transfusion in the last 14 days: absolute neutrophil count =1.5×109/L, hemoglobin =80 g/L, platelets =75×109/L (no platelet transfusion within 14 days); if accompanied with bone marrow invasion, neutrophils =1.0×109/L, platelets =50×109/L. - Biochemistry: Total bilirubin =1.5×ULN or =3.0×ULN in Gilbert's syndrome, AST or ALT =2.5×ULN, serum creatinine =1.5×ULN or calculated creatinine clearance =60 mL/min (Cockcroft-Gault formula). - Coagulation function: International normalized ratio (INR) and activated partial thrombin time = 1.5 × ULN. Exclusion Criteria: - 1) Present or prior history of other malignancies (except cured carcinoma in situ of cervix and basal cell carcinoma of skin), unless there is radical treatment and no evidence of recurrence or metastasis within the last 2 years. - 2) Lymphomas involved the central nervous system. - 3) Patients with history of organ transplantation or allogeneic hematopoietic stem cell transplantation; patients who have received autologous hematopoietic stem cell transplantation or CAR-T treatment within the past 3 months, - 4) Patients who are suitable and ready for autologous stem cell transplantation. - 5) History of eye surgery or trauma within 3 months before the screening visit, history of serious eye infection or the most recent eye surgery within 4 weeks before the screening visit. - 6) Has had active and uncontrolled autoimmune hemocytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura. - 7) Has had uncontrolled or significant cardiovascular diseases, including: - 8) Women who are lactating or pregnant. - 9) Women of child-bearing potential who do not agree to have two pregnancy tests prior to first dose (at least one of tests is serum pregnancy test) and the test result shall be negative. - 10) Male patients who do not agree to the birth control measures. - 11) Any conditions that in the opinion of the investigator considers inappropriate to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MS-553
MS-553 oral tablet BID x 28-days

Locations

Country Name City State
China Beijing Cancer Hospital Beijing

Sponsors (2)

Lead Sponsor Collaborator
MingSight Pharmaceuticals, Inc Shenzhen MingSight Relin Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of dose limiting toxicity (DLT) First cycle (28 days)
Primary Incidence and severity of adverse events up to 24 months
Primary To determine the MTD and RP2D of oral MS-553 in patients with BCL about 8 months
Secondary Objective response rate (ORR) up to 24 months
Secondary Duration of response (DOR) up to 24 months
Secondary progression-free survival (PFS) up to 24 months
Secondary overall survival (OS) up to 24 months
Secondary time to progression (TTR) up to 24 months
Secondary disease control rate (DCR) up to 24 months
Secondary Pharmacokinetics parameters: Cmax within the first 2 cycles (56 days)
Secondary Pharmacokinetics parameters: Tmax within the first 2 cycles (56 days)
Secondary Pharmacokinetics parameters: T1/2 within the first 2 cycles (56 days)
Secondary Pharmacokinetics parameters: AUC0-12 within the first 2 cycles (56 days)
Secondary Pharmacokinetics parameters: CL/F within the first 2 cycles (56 days)
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