NCT06979076

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
29mo left

Started Jul 2026

Typical duration for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

2.2 years

First QC Date

May 2, 2025

Last Update Submit

September 23, 2025

Conditions

CLL (Chronic Lymphocytic Leukemia)SLL (Small Lymphocytic Lymphoma)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

MS-553, dose schedule 1 (DS1)

EXPERIMENTAL
Drug: MS-553, DS1

MS-553, dose schedule 2 (DS2)

EXPERIMENTAL
Drug: MS-553, DS2

Interventions

MS-553, DS1DRUG

Oral, Dose Schedule 1

MS-553, dose schedule 1 (DS1)
MS-553, DS2DRUG

Oral, Dose Schedule 2

MS-553, dose schedule 2 (DS2)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older.
  • Diagnosis of CLL or SLL:
  • History of histologically documented CLL or SLL that meets iwCLL diagnostic criteria according to the 2018 guidelines, and
  • Indication for treatment as defined by the 2018 iwCLL guidelines, or the need for disease reduction prior to allogeneic transplantation.-

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, B-CellLeukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Kai Zhang

CONTACT

858-699-7681kzhang@mingsight.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2025

First Posted

May 18, 2025

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

September 29, 2025

Record last verified: 2025-09