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

MingSight Pharmaceuticals

Status and phase: Begins enrollment this month; Phase 2; Phase 1

Conditions: CLL (Chronic Lymphocytic Leukemia); SLL (Small Lymphocytic Lymphoma)

Treatments: Drug: MS-553, DS1; Drug: MS-553, DS2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06979076

MS-553-201-CLL

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

MS-553, dose schedule 1 (DS1)

Experimental group

Treatment:

Drug: MS-553, DS1

MS-553, dose schedule 2 (DS2)

Experimental group

Treatment:

Drug: MS-553, DS2