A Study of MS-553 in Patients With Relapsed or Refractory B-cell Lymphoma

Chronic Lymphocytic Leukemia (CLL) Clinical Trial

Official title:

A Phase I/II Study to Evaluate the Safety and Efficacy of the MS-553 in Patients With Relapsed or Refractory B-cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05720052
• Other study ID #: 2020-003-CN
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia (CLL)
• Diffuse Large B-cell Lymphoma (DLBCL)
• Follicular Lymphoma (FL)
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma (MCL)
• Marginal Zone Lymphoma (MZL)
• Relapsed or Refractory B-cell Lymphoma
• Small Lymphocytic Lymphoma (SLL)

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)