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

NCT05720052 | Terminated Phase 1 DMC

• 1 other identifier: 2020-003-CN
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (11)

• Objective response rate (ORR)

  up to 24 months

• Duration of response (DOR)

  up to 24 months

• progression-free survival (PFS)

  up to 24 months

• overall survival (OS)

  up to 24 months

• time to progression (TTR)

  up to 24 months

Study Arms (1)

Single arm

EXPERIMENTAL

dose exploration

Drug: MS-553

Interventions

MS-553 DRUG

MS-553 oral tablet BID x 28-days

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Patients in Phase I study will be enrolled with refractory or relapsed B-cell non-Hodgkin lymphoma.
• \) 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.
• \) Eastern Cooperative Oncology Group (ECOG) performance status score is 0\~2.
• \) Have life expectancy ≥ 3 months.
• \) 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.

You may not qualify if:

• \) 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.
• \) Lymphomas involved the central nervous system.
• \) 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,
• \) Patients who are suitable and ready for autologous stem cell transplantation.
• \) 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.
• \) Has had active and uncontrolled autoimmune hemocytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.
• \) Has had uncontrolled or significant cardiovascular diseases, including:
• \) Women who are lactating or pregnant.
• \) 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.
• \) Male patients who do not agree to the birth control measures.
• \) Any conditions that in the opinion of the investigator considers inappropriate to participate in the study.

Sponsors & Collaborators

• MingSight Pharmaceuticals, Inc: lead
• Shenzhen MingSight Relin Pharmaceutical Co., Ltd: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

Location

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell, Marginal Zone

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 9, 2023
• Study Start: February 6, 2023
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

CN (1)