Back to resultsA Study to Investigate the Efficacy and Safety of MS-553 in CLL/SLL
Primary Purpose
Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
MS-553
Sponsored by
About this trial
This is an interventional treatment trial for Lymphocytic Leukemia
Eligibility Criteria
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:
- Treatment of autoimmune hemolysis or autoimmune thrombocytopenia associated with CLL/SLL;
- 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.
Sites / Locations
- Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
MS-553 Low Dose
MS-553 Mid Dose-1
MS-553 Mid Dose-2
MS-553 High Dose
Arm Description
MS-553 Low Dose PO BID
MS-553 Mid Dose-1 PO BID
MS-553 Mid Dose-2 PO BID
MS-553 High Dose PO BID
Outcomes
Primary Outcome Measures
Incidence of dose limiting toxicities
Secondary Outcome Measures
Incidence and severity of adverse events
Overall response rate
Time to tumor response
Disease control rate
Progression free survival
Overall survival
Assessment of minimal residual disease
Full Information
NCT ID
NCT05272813
First Posted
February 18, 2022
Last Updated
October 17, 2023
Sponsor
Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05272813
Brief Title
A Study to Investigate the Efficacy and Safety of MS-553 in CLL/SLL
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphocytic Leukemia, Small Lymphocytic Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Stage 1 3+3 dose escalation study with expansion to Stage 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MS-553 Low Dose
Arm Type
Experimental
Arm Description
MS-553 Low Dose PO BID
Arm Title
MS-553 Mid Dose-1
Arm Type
Experimental
Arm Description
MS-553 Mid Dose-1 PO BID
Arm Title
MS-553 Mid Dose-2
Arm Type
Experimental
Arm Description
MS-553 Mid Dose-2 PO BID
Arm Title
MS-553 High Dose
Arm Type
Experimental
Arm Description
MS-553 High Dose PO BID
Intervention Type
Drug
Intervention Name(s)
MS-553
Intervention Description
MS-553
Primary Outcome Measure Information:
Title
Incidence of dose limiting toxicities
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events
Time Frame
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
Title
Overall response rate
Time Frame
up to 24 months
Title
Time to tumor response
Time Frame
During intervention
Title
Disease control rate
Time Frame
During intervention
Title
Progression free survival
Time Frame
During intervention
Title
Overall survival
Time Frame
During intervention
Title
Assessment of minimal residual disease
Time Frame
During intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Treatment of autoimmune hemolysis or autoimmune thrombocytopenia associated with CLL/SLL;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ling Yang
Phone
+8613421382136
Email
yangling@relin.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Zhang, MD
Organizational Affiliation
Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Xicheng District
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojun Huang, MD
12. IPD Sharing Statement
Learn more about this trial
A Study to Investigate the Efficacy and Safety of MS-553 in CLL/SLL
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