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

  • STATUS
    Recruiting
  • End date
    Sep 10, 2025
  • participants needed
    48
  • sponsor
    Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
Updated on 10 July 2022
btk inhibitor

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.

Details
Condition Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Treatment MS-553
Clinical Study IdentifierNCT05272813
SponsorShenzhen MingSight Relin Pharmaceuticals Co., Ltd.
Last Modified on10 July 2022

Eligibility

Yes No Not Sure

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
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