A Study Of The Selective PKC-β Inhibitor MS- 553
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ClinicalTrials.gov Identifier: NCT03492125 |
Recruitment Status :
Recruiting
First Posted : April 10, 2018
Last Update Posted : March 15, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Aggressive Lymphoma | Drug: MS-553 Drug: acalabrutinib Drug: venetoclax Drug: Rituximab Drug: obinutuzumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 117 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | a limited 3+3 phase 1 dose escalation study with expansion cohorts |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | May 25, 2018 |
Estimated Primary Completion Date : | April 15, 2024 |
Estimated Study Completion Date : | June 15, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Phase I Dose Escalation Cohort A1 (MS-553 Monotherapy)
R/R CLL/SLL patients
|
Drug: MS-553
Oral, multiple dose levels |
Experimental: Phase II Expansion Cohort A2 (MS-553 Monotherapy)
R/R CLL/SLL patients
|
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 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: acalabrutinib Oral |
Experimental: Phase II Expansion Cohort B2
BTK inhibitor naïve CLL/SLL patients
|
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 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: MS-553
Oral, multiple dose levels Drug: venetoclax Oral
Other Names:
Drug: Rituximab IV
Other Names:
Drug: obinutuzumab IV
Other Name: Gazyva |
Experimental: Experimental: Phase II Expansion Cohort C2
Bcl-2 inhibitor naïve CLL/SLL patients
|
Drug: MS-553
Oral recommended phase 2 dose of MS-553 Drug: venetoclax Oral
Other Names:
Drug: Rituximab IV
Other Names:
Drug: obinutuzumab IV
Other Name: Gazyva |
- 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. [ Time Frame: Assessments for DLT and TEAE will occur during cycle 1. The primary endpoint will be the rate of DLT and TEAE requiring study drug discontinuation in the first 28 days ]The primary endpoint of this study is the incidence rate of dose-limiting toxicities and treatment-emergent adverse events requiring study drug discontinuation
- 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. [ Time Frame: Screening, post cycle 3 and 6 cycles (each cycle is 28 days) ]This will be assessed according to the International Workshop on Chronic Lymphocytic Leukemia Response Criteria with modifications for treatment-related lymphocytosis.
- 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
- Pharmacokinetic (PK) parameters of MS-553 [ Time Frame: Cycle 1 day 1, Cycle 1 Day 8 (each cycle is 28 days) ]Evaluate Tmax
- Pharmacokinetic (PK) parameters of MS-553 [ Time Frame: Cycle 1 Day 1, Cyle 1 Day 8 (each cycle is 28 days) ]Evaluate t1/2
- 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-∞)
- 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 ]
- 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) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- 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
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible for the primary escalation and expansion cohorts of this study:
- 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.
- Active and uncontrolled autoimmune cytopenia(s)
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492125
Contact: Kai Zhang | 858-699-7681 | kzhang@mingsight.com | |
Contact: Gerald Messerschmidt, MD | 610-613-3882 |
United States, Michigan | |
University Of Michigan Comprehensive Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Roxana Taralunga 734-232-0773 roxanat@med.umich.edu | |
Principal Investigator: Christine Ye, MD | |
United States, New York | |
Columbia University, Herbert Irving Comprehensive Cancer Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Emma Bentley-Hicks 212-304-5558 eb3416@cumc.columbia.edu | |
Principal Investigator: Nicole Lamanna, MD | |
United States, Ohio | |
The Ohio State University, James Comprehensive Cancer Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Lindsey Rike 614-685-6559 Lindsey.Rike@osumc.edu | |
Principal Investigator: James Blachly, MD | |
United States, Texas | |
MD Anderson Cancer Center, Department of Leukemia | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Sheri Allred 713-792-2882 slallred@mdanderson.org | |
Principal Investigator: Nitin Jain, MD | |
United States, Utah | |
Huntsman Cancer Institute | Recruiting |
Salt Lake City, Utah, United States, 84112 | |
Contact: McKell Reese 801-587-4775 McKell.Reese@hsc.utah.edu | |
Principal Investigator: Deborah Stephens, MD |
Responsible Party: | MingSight Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT03492125 |
Other Study ID Numbers: |
MS-553-103 |
First Posted: | April 10, 2018 Key Record Dates |
Last Update Posted: | March 15, 2023 |
Last Verified: | November 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Chronic Disease |
Disease Attributes Pathologic Processes Rituximab Obinutuzumab Venetoclax Acalabrutinib Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |