A Study to Investigate the Efficacy and Safety of MS-553 in CLL/SLL

A Phase I/II Study to Investigate the Efficacy and Safety of MS-553 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This is a Phase I/II, single arm, multi-center, open-label clinical trial of MS-553 in patients with CLL/SLL whose disease relapsed after or was refractory to at lease 1 prior therapy (chemotherapy and/or targeted drug therapy, which must include BTK inhibitor therapy) and who are indicated for treatment per IWCLL2018.

Study Overview

• Status: Terminated
• Conditions: Small Lymphocytic Lymphoma; Lymphocytic Leukemia
• Intervention / Treatment: Drug: MS-553

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Xicheng District
    • Beijing, Xicheng District, China
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older, male or female.
• Diagnosis of CLL/SLL per IWCLL2018 criteria.
• Patients with relapsed or refractory CLL/SLL who have failed at least 1 prior therapy (chemotherapy and/or targeted drug therapy, which must include BTK inhibitor therapy), are indicated for treatment per IWCLL2018.
• Measurable lesions detected by contrast-enhanced computed tomography (CT): at least one lymph node with a maximum axis of more than 1.5 cm and one measurable vertical dimension.
• WHO/ECOG performance status of 0 to 2.
• Patients with an estimated survival of more than 3 months.

Exclusion Criteria:

• Biopsy-proven and pathologically confirmed current or past transformation to Richter's syndrome.
• Patients with active and uncontrolled autoimmune cytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.

• Patients who have received any of the following treatments within 14 days prior to the first dose:

  • Major surgery;

  • Glucocorticoids (at a dose equal to or greater than 20 mg/day prednisone or equivalent), unless used by inhalation, topical or intraarticular route, or unless necessary for premedication before and after iodinated contrast dye. After discussion with the Sponsor, steroid therapy at high doses for an extended period may be allowed under the following circumstances:

    1. Treatment of autoimmune hemolysis or autoimmune thrombocytopenia associated with CLL/SLL;
    2. Short-term (within 14 days) use to treat inactive infections of diseases unrelated to CLL/SLL (e.g. arthritis, asthma), which results in acute exacerbation, including steroid dose modifications required for adrenal insufficiency;
  • Cytotoxic chemotherapy or biologic therapy, excepting BCR pathway kinase inhibitors for which a washout of 24 hours prior to the first dose is required.
• Toxicity from prior anti-tumor therapy (chemotherapy, radiotherapy, or biotherapy) did not restore to ≤ Grade 1 (except for alopecia); atrial fibrillation from prior treatment with BTK inhibitors did not restore to ≤ Grade 2.
• Central nervous system (CNS) leukemia or lymphoma, including a history of asymptomatic, previously treated CNS disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MS-553 Low Dose; MS-553 Low Dose PO BID	Drug: MS-553; MS-553
Experimental: MS-553 Mid Dose-1; MS-553 Mid Dose-1 PO BID	Drug: MS-553; MS-553
Experimental: MS-553 Mid Dose-2; MS-553 Mid Dose-2 PO BID	Drug: MS-553; MS-553
Experimental: MS-553 High Dose; MS-553 High Dose PO BID	Drug: MS-553; MS-553

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of dose limiting toxicities	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events	Assessed throughout the study from the time of first dose of study drug until 30 days after the patient's last dose of study drug or until the event has resolved, stabilized, or an outcome reached, whichever comes first regardless of timing of EoT visit
Overall response rate	up to 24 months
Time to tumor response	During intervention
Disease control rate	During intervention
Progression free survival	During intervention
Overall survival	During intervention
Assessment of minimal residual disease	During intervention

Collaborators and Investigators

• Sponsor: Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
• Investigators: Study Director: Kai Zhang, MD, Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Actual): November 28, 2023
• Study Completion (Actual): November 28, 2023

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Hematologic Diseases; Leukemia, B-Cell; Chronic Disease; Lymphoma; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: 2020-001-CN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No