A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients With Refractory or Relapsed CLL/SLL

Phase 1

Not yet recruiting

• Conditions: CLL (Chronic Lymphocytic Leukemia); SLL (Small Lymphocytic Lymphoma)
• Interventions: Drug: MS-553, DS1; Drug: MS-553, DS2

• Registration Number: NCT06979076
• Lead Sponsor: MingSight Pharmaceuticals, Inc

Brief Summary

A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients with Refractory or Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-02
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Study Start: 2025-07
• Primary Completion: 2027-09
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Age 18 years or older.

2. Diagnosis of CLL or SLL:

   1. History of histologically documented CLL or SLL that meets iwCLL diagnostic criteria according to the 2018 guidelines, and
   2. Indication for treatment as defined by the 2018 iwCLL guidelines, or the need for disease reduction prior to allogeneic transplantation.-

Exclusion Criteria

1. Current transformation of CLL/SLL non-Hodgkin lymphoma or Hodgkin lymphoma.
2. Active and uncontrolled autoimmune cytopenia(s).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MS-553, dose schedule 1 (DS1)	MS-553, DS1	-
MS-553, dose schedule 2 (DS2)	MS-553, DS2	-

Primary Outcome Measures

Name	Time	Method
The occurrence of AEs and SAEs, with abnormal laboratory tests results, abnormal physical examination findings, abnormal vital signs, and abnormal ECG readings	Through study completion, an average of 2 years