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

Sponsor
Shenzhen MingSight Relin Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05272813
Collaborator
(none)
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40.1
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Stage 1 3+3 dose escalation study with expansion to Stage 2Stage 1 3+3 dose escalation study with expansion to Stage 2
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 28, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of dose limiting toxicities [28 days]

Secondary Outcome Measures

  1. 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]

  2. Overall response rate [up to 24 months]

  3. Time to tumor response [During intervention]

  4. Disease control rate [During intervention]

  5. Progression free survival [During intervention]

  6. Overall survival [During intervention]

  7. Assessment of minimal residual disease [During intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University People's Hospital Beijing Xicheng District China

Sponsors and Collaborators

  • Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05272813
Other Study ID Numbers:
  • 2020-001-CN
First Posted:
Mar 9, 2022
Last Update Posted:
Jun 29, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2022