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

NCT05272813 | Terminated Phase 1

• 1 other identifier: 2020-001-CN
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

• Incidence of dose limiting toxicities

  28 days

Secondary Outcomes (7)

• 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

Study Arms (4)

MS-553 Low Dose

EXPERIMENTAL

MS-553 Low Dose PO BID

Drug: MS-553

MS-553 Mid Dose-1

EXPERIMENTAL

MS-553 Mid Dose-1 PO BID

Drug: MS-553

MS-553 Mid Dose-2

EXPERIMENTAL

MS-553 Mid Dose-2 PO BID

Drug: MS-553

MS-553 High Dose

EXPERIMENTAL

MS-553 High Dose PO BID

Drug: MS-553

Interventions

MS-553 DRUG

MS-553

MS-553 High Dose; MS-553 Low Dose; MS-553 Mid Dose-1; MS-553 Mid Dose-2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Xicheng District, China

Location

MeSH Terms

Conditions

Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Kai Zhang, MD

  Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Stage 1 3+3 dose escalation study with expansion to Stage 2

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 9, 2022
• Study Start: April 28, 2022
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

CN (1)