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Protein Kinase Inhibitor

MS-553 for Chronic Lymphocytic Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by MingSight Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL): History of histologically documented CLL or SLL that meets IWCLL diagnostic criteria according to the 2008 guidelines, and Indication for treatment as defined by the 2008 IWCLL guidelines, or the need for disease reduction prior to allogeneic transplantation
Must not have
Active and uncontrolled autoimmune cytopenia(s)
Any of the following prior therapies within 14 days prior to cycle 1, day 1: Major surgery, Corticosteroids greater than 20 mg / day prednisone (or equivalent), unless used by inhalation or topical route, or unless necessary for premedication before iodinated contrast dye, or for autoimmune hemolytic anemia, Cytotoxic chemotherapy or biologic therapy, excepting BCR pathway kinase inhibitors for which no wash out is required (but must be stopped before cycle 1 day 1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day1, cycle 1 day 8, (each cycle is 28 days)
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing a new drug called MS-553, which blocks a protein that helps cancer cells grow. It is aimed at patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. By blocking this protein, the drug hopes to stop the cancer from growing and help patients who do not respond well to other treatments.

Who is the study for?
This trial is for adults over 18 with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who meet specific medical guidelines and need treatment. People can't join if they've had major surgery recently, have transformed CLL/SLL, uncontrolled autoimmune issues, or used certain therapies within the last two weeks.
What is being tested?
The study tests MS-553's safety and effectiveness in different doses for patients with CLL/SLL. It will be combined with other drugs like venetoclax, Rituximab, obinutuzumab, and acalabrutinib to see how well it works.
What are the potential side effects?
Possible side effects of MS-553 may include reactions at the infusion site, fatigue, nausea. The other medications used can also cause immune system reactions, infections due to low blood cell counts, bleeding problems and heart rhythm changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with CLL or SLL and need treatment according to 2008 guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active autoimmune condition affecting my blood cells.
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I haven't had major surgery, high-dose steroids, or certain cancer treatments in the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day1, cycle 1 day 8, (each cycle is 28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day1, cycle 1 day 8, (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The primary objective of this study is to evaluate the safety of MS-553 in patients with CLL/SLL whose disease relapsed after or was refractory to at least one prior therapy.
Secondary study objectives
To evaluate the clinical activity (i.e. the overall response rate (ORR) of MS-553 in patients with CLL/SLL whose disease relapsed after or was refractory to at least one prior therapy.
Other study objectives
Pharmacokinetic (PK) parameters of MS-553

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups
Experimental Treatment
Group I: Phase II Expansion Cohort B3Experimental Treatment2 Interventions
BTK inhibitor naïve CLL/SLL patients with certain gene mutations
Group II: Phase II Expansion Cohort B2Experimental Treatment2 Interventions
BTK inhibitor naïve CLL/SLL patients
Group III: Phase II Expansion Cohort A3 (MS-553 Monotherapy)Experimental Treatment1 Intervention
patients with aggressive lymphoma
Group IV: Phase II Expansion Cohort A2 (MS-553 Monotherapy)Experimental Treatment1 Intervention
R/R CLL/SLL patients
Group V: Phase I Dose Escalation Cohort A1 (MS-553 Monotherapy)Experimental Treatment1 Intervention
R/R CLL/SLL patients
Group VI: Phase I Combination Dose Escalation Cohort C1Experimental Treatment4 Interventions
Bcl-2 inhibitor naïve CLL/SLL patients
Group VII: Phase I Combination Dose Escalation Cohort B1Experimental Treatment2 Interventions
BTK inhibitor naïve CLL/SLL patients
Group VIII: Experimental: Phase II Expansion Cohort C2Experimental Treatment4 Interventions
Bcl-2 inhibitor naïve CLL/SLL patients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MS-553
2015
Completed Phase 1
~40
Venetoclax
FDA approved
Rituximab
FDA approved
Obinutuzumab
FDA approved
Acalabrutinib
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Chronic Lymphocytic Leukemia (CLL) include BTK inhibitors (e.g., ibrutinib, acalabrutinib), BCL2 inhibitors (e.g., venetoclax), and emerging therapies like PKC-β inhibitors (e.g., MS-553). BTK inhibitors block Bruton's tyrosine kinase, a key enzyme in the B-cell receptor signaling pathway, thereby inhibiting CLL cell proliferation and survival. BCL2 inhibitors promote apoptosis in CLL cells by targeting the BCL2 protein, which prevents programmed cell death. PKC-β inhibitors, such as MS-553, selectively inhibit protein kinase C-beta, which plays a role in cell survival and proliferation. These targeted therapies are crucial for CLL patients as they offer more precise treatment options with potentially fewer side effects compared to traditional chemotherapy, improving both survival rates and quality of life.
New angles of attack in the fight against chronic lymphocytic leukemia: the advent of novel non-chemotherapeutic agents.

Find a Location

Who is running the clinical trial?

MingSight Pharmaceuticals, Inc.Lead Sponsor
MingSight Pharmaceuticals, IncLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

MS-553 (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03492125 — Phase 1 & 2
Chronic Lymphocytic Leukemia Research Study Groups: Phase I Combination Dose Escalation Cohort C1, Experimental: Phase II Expansion Cohort C2, Phase II Expansion Cohort A2 (MS-553 Monotherapy), Phase I Combination Dose Escalation Cohort B1, Phase II Expansion Cohort A3 (MS-553 Monotherapy), Phase I Dose Escalation Cohort A1 (MS-553 Monotherapy), Phase II Expansion Cohort B2, Phase II Expansion Cohort B3
Chronic Lymphocytic Leukemia Clinical Trial 2023: MS-553 Highlights & Side Effects. Trial Name: NCT03492125 — Phase 1 & 2
MS-553 (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03492125 — Phase 1 & 2
~9 spots leftby Oct 2025