CLL (Chronic Lymphocytic Leukemia)Phase 1/2NCT06979076
A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients With Refractory or Relapsed CLL/SLL
A Phase 1/2 study testing MS-553, DS1 and MS-553, DS2 in people with CLL (Chronic Lymphocytic Leukemia) and SLL (Small Lymphocytic Lymphoma), run by MingSight Pharmaceuticals, Inc.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLL (Chronic Lymphocytic Leukemia), SLL (Small Lymphocytic Lymphoma)
- What is being tested?
- MS-553, DS1 and MS-553, DS2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.-
Who cannot join
- Current transformation of CLL/SLL non-Hodgkin lymphoma or Hodgkin lymphoma.
- Active and uncontrolled autoimmune cytopenia(s).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients with Refractory or Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Being tested
- MS-553, DS1, MS-553, DS2
- Medical subject headings
- Leukemia, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS-553, DS1Drug
Oral, Dose Schedule 1
MS-553, DS2Drug
Oral, Dose Schedule 2
| Study group | Role | What they receive |
|---|---|---|
| MS-553, dose schedule 1 (DS1) | Experimental | Not described Receives: Drug: MS-553, DS1 |
| MS-553, dose schedule 2 (DS2) | Experimental | Not described Receives: Drug: MS-553, DS2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of AEs and SAEs, with abnormal laboratory tests results, abnormal physical examination findings, abnormal vital signs, and abnormal ECG readings
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study startJul 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLL (Chronic Lymphocytic Leukemia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MingSight Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979076
- Sponsor's protocol ID
- MS-553-201-CLL
- Status last verified
- Sep 2025
- First submitted
- 2 May 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- ClinicalTrials.gov ID
- NCT06979076
- Acronym / sponsor ID
- MS-553-201-CLL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- MingSight Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients with Refractory or Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS-553, dose schedule 1 (DS1) | Experimental | Drug: MS-553, DS1 |
| MS-553, dose schedule 2 (DS2) | Experimental | Drug: MS-553, DS2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Diagnosis of CLL or SLL:
Key exclusion criteria (2 listed)
- Current transformation of CLL/SLL non-Hodgkin lymphoma or Hodgkin lymphoma.
- Active and uncontrolled autoimmune cytopenia(s).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MS-553, DS1Oral, Dose Schedule 1 | Drug | MS-553, dose schedule 1 (DS1) |
| MS-553, DS2Oral, Dose Schedule 2 | Drug | MS-553, dose schedule 2 (DS2) |
Primary outcome
The occurrence of AEs and SAEs, with abnormal laboratory tests results, abnormal physical examination findings, abnormal vital signs, and abnormal ECG readings
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MS-553, DS1 and MS-553, DS2 in people with CLL (Chronic Lymphocytic Leukemia) and SLL (Small Lymphocytic Lymphoma), run by MingSight Pharmaceuticals, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Zhang (858-699-7681, kzhang@mingsight.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of AEs and SAEs, with abnormal laboratory tests results, abnormal physical examination findings, abnormal vital signs, and abnormal ECG readings (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.