A Study Of The Selective PKC-β Inhibitor MS- 553

April 7, 2025 updated by: MingSight Pharmaceuticals, Inc

A Phase I/II Dose-Escalation and Expansion Study of the Selective PKC-β Inhibitor MS-553 in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

A Phase I/II Dose-Escalation and Expansion Study Of The Selective PKC-Β Inhibitor MS-553 In Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Gerald Messerschmidt, MD
  • Phone Number: 610-613-3882

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University, Herbert Irving Comprehensive Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University, James Comprehensive Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center, Department of Leukemia
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

To be eligible for inclusion in the primary escalation and expansion cohort 1 in this study, patients must meet all of the following criteria:

  1. Age 18 years or older

  2. Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL):

    1. History of histologically documented CLL or SLL that meets IWCLL diagnostic criteria according to the 2008 guidelines, and
    2. Indication for treatment as defined by the 2008 IWCLL guidelines, or the need for disease reduction prior to allogeneic transplantation

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for the primary escalation and expansion cohorts of this study:

  1. Current or past transformation of CLL/SLL to prolymphocytic leukemia (PLL), non-Hodgkin lymphoma, or Hodgkin lymphoma aggressive lymphoma outlined in the inclusion criteria for the optional cohort.
  2. Active and uncontrolled autoimmune cytopenia(s)

  3. Any of the following prior therapies within 14 days prior to cycle 1, day 1:

    1. Major surgery
    2. 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
    3. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase I Dose Escalation Cohort A1 (MS-553 Monotherapy)
R/R CLL/SLL patients
Drug: MS-553
Oral, multiple dose levels
Drug: MS-553
Oral recommended phase 2 dose of MS-553
Experimental: Phase II Expansion Cohort A2 (MS-553 Monotherapy)
R/R CLL/SLL patients
Drug: MS-553
Oral, multiple dose levels
Drug: MS-553
Oral recommended phase 2 dose of MS-553
Experimental: Phase II Expansion Cohort A3 (MS-553 Monotherapy)
patients with aggressive lymphoma
Drug: MS-553
Oral, multiple dose levels
Drug: MS-553
Oral recommended phase 2 dose of MS-553
Experimental: Phase I Combination Dose Escalation Cohort B1
BTK inhibitor naïve CLL/SLL patients
Drug: MS-553
Oral, multiple dose levels
Drug: MS-553
Oral recommended phase 2 dose of MS-553
Drug: acalabrutinib
Oral
Experimental: Phase II Expansion Cohort B2
BTK inhibitor naïve CLL/SLL patients
Drug: MS-553
Oral, multiple dose levels
Drug: MS-553
Oral recommended phase 2 dose of MS-553
Drug: acalabrutinib
Oral
Experimental: Phase II Expansion Cohort B3
BTK inhibitor naïve CLL/SLL patients with certain gene mutations
Drug: MS-553
Oral, multiple dose levels
Drug: MS-553
Oral recommended phase 2 dose of MS-553
Drug: acalabrutinib
Oral
Experimental: Phase I Combination Dose Escalation Cohort C1
Bcl-2 inhibitor naïve CLL/SLL patients
Drug: Rituximab
IV
Other Names:
  • Rituxan
  • MabThera
Drug: MS-553
Oral, multiple dose levels
Drug: MS-553
Oral recommended phase 2 dose of MS-553
Drug: venetoclax
Oral
Other Names:
  • Venclexta
  • Venclyxto
Drug: obinutuzumab
IV
Other Names:
  • Gazyva
Experimental: Experimental: Phase II Expansion Cohort C2
Bcl-2 inhibitor naïve CLL/SLL patients
Drug: Rituximab
IV
Other Names:
  • Rituxan
  • MabThera
Drug: MS-553
Oral, multiple dose levels
Drug: MS-553
Oral recommended phase 2 dose of MS-553
Drug: venetoclax
Oral
Other Names:
  • Venclexta
  • Venclyxto
Drug: obinutuzumab
IV
Other Names:
  • Gazyva

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Incidence Rate of DLT and TEAE Requiring Study Drug Discontinuation
Time Frame: Assessments for DLT and TEAE will occur during Cycle 1 (28 days) for A1 Cohort and B1 Cohort and Cycles 1-4 (up to 112 days) for C1 Cohort.
DLT are defined as any of the following treatment-emergent events occurring during the DLT evaluation period. 1. Death 2. Hematologic toxicities: • Grade 4 neutropenia for ≥ 7 days • Grade 3 febrile neutropenia: absolute neutrophil count (ANC) 38.3°C (101°F) or a sustained temperature ≥38°C (100.4°F) for > 1 hour • Grade 4 thrombocytopenia ≥ 14 days (patients with baseline platelet count of ≥ 50 x 109 /L) • Grade 4 thrombocytopenia ≥ 28 days (patients with baseline platelet count < 50 x 10 9 /L) • ≥ Grade 3 thrombocytopenia associated with ≥ Grade 2 hemorrhage • New ≥ Grade 3 anemia requiring transfusion in a patient previously transfusion independent. 3. Nonhematologic toxicities: • Any other ≥ Grade 3 toxicity not reversed to any one of the following three conditions in 7 days with appropriate intervention: a) baseline; b) < Grade 1; or c) a status considered to be controlled by the SRC. • Any TEAE requiring >25% of doses of scheduled study drug to be withheld during the DLT period
Assessments for DLT and TEAE will occur during Cycle 1 (28 days) for A1 Cohort and B1 Cohort and Cycles 1-4 (up to 112 days) for C1 Cohort.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The ORR of MS-553 in Patients With CLL/SLL Whose Disease Relapsed After or Was Refractory to at Least One Prior Therapy
Time Frame: Evaluation of the efficacy endpoints related to response will incorporate the data from the first 9 cycles (up to 252 days) of treatment.
This will be assessed according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Response Criteria with modifications for treatment-related lymphocytosis. Any patient who receives at least one cycle of study therapy is evaluable for response.
Evaluation of the efficacy endpoints related to response will incorporate the data from the first 9 cycles (up to 252 days) of treatment.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (PK) parameters of MS-553
Time Frame: Time Frame: Cycle 1 day1, Cycle 1 Day 8, Cycle 2 Day 1(each cycle is 28 days)
Evaluate Cmax
Time Frame: Cycle 1 day1, Cycle 1 Day 8, Cycle 2 Day 1(each cycle is 28 days)
Pharmacokinetic (PK) parameters of MS-553
Time Frame: Cycle 1 day 1, Cycle 1 Day 8 (each cycle is 28 days)
Evaluate Tmax
Cycle 1 day 1, Cycle 1 Day 8 (each cycle is 28 days)
Pharmacokinetic (PK) parameters of MS-553
Time Frame: Cycle 1 Day 1, Cyle 1 Day 8 (each cycle is 28 days)
Evaluate t1/2
Cycle 1 Day 1, Cyle 1 Day 8 (each cycle is 28 days)
Pharmacokinetic (PK) parameters of MS-553
Time Frame: Cycle 1 day1, Cycle 1 Day 8, (each cycle is 28 days)
Evaluate AUC (0-24; 0-∞)
Cycle 1 day1, Cycle 1 Day 8, (each cycle is 28 days)
Evaluate pharmacodynamics biomarker,ability of MS-553 to inhibit PKC signaling (phosphorylation of PKC Beta substrate in patients with CLL/SLL treated with MS-553
Time Frame: C1D1 Pre-dose and C1D8 pre dose and 3 hours post dose
C1D1 Pre-dose and C1D8 pre dose and 3 hours post dose
Evaluate pharmacogenomic biomarkers in patients with CLL/SLL treated with MS-553 to compare germline DNA with tumor DNA via changes in sequence analysis
Time Frame: C1D1 and the 1st day of each cycle and end of treatment (each cycle is 28 days)
C1D1 and the 1st day of each cycle and end of treatment (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MingSight Pharmaceuticals, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS-553-103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Lymphocytic Leukemia

Clinical Trials on Rituximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings