TerminatedNCT03492125Updated Apr 10, 2025Results posted

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

A Phase 1/2 interventional study of MS-553 and MS-553 in Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma and Aggressive Lymphoma, sponsored by MingSight Pharmaceuticals, Inc. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-10.

Sponsored by MingSight Pharmaceuticals, Inc · Phase 1/2, Interventional, and Treatment

Why this study was terminated

The study is terminated due to major protocol revisions. A new study in CLL patients is planned.

Phase: Phase 1/2
Study type: Interventional
Enrollment: 60
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

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

Conditions studied

Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Aggressive Lymphoma

Browse trials for

Leukemia, Lymphocytic, Chronic, B-Cell 2,036

In context

Leukemia, Lymphocytic, Chronic, B-Cell

2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.

This study's enrollment of 60 is above the median of 39 across 1,603 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.

Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →

Lead sponsor

MingSight Pharmaceuticals, Inc is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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):
1. History of 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 transplantation

Exclusion criteria

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 cytopenia(s)
Any of the following prior therapies within 14 days prior to cycle 1, day 1:
1. Major surgery
2. 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)

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 60 participants (actual)

Study arms

Experimental
Phase I Dose Escalation Cohort A1 (MS-553 Monotherapy)
R/R CLL/SLL patients
Drug: MS-553
Experimental
Phase II Expansion Cohort A2 (MS-553 Monotherapy)
R/R CLL/SLL patients
Drug: MS-553
Experimental
Phase II Expansion Cohort A3 (MS-553 Monotherapy)
patients with aggressive lymphoma
Drug: MS-553
Experimental
Phase I Combination Dose Escalation Cohort B1
BTK inhibitor naïve CLL/SLL patients
Drug: MS-553 · Drug: acalabrutinib
Experimental
Phase II Expansion Cohort B2
BTK inhibitor naïve CLL/SLL patients
Drug: MS-553 · Drug: acalabrutinib
Experimental
Phase II Expansion Cohort B3
BTK inhibitor naïve CLL/SLL patients with certain gene mutations
Drug: MS-553 · Drug: acalabrutinib
Experimental
Phase I Combination Dose Escalation Cohort C1
Bcl-2 inhibitor naïve CLL/SLL patients
Drug: MS-553 · Drug: venetoclax · Drug: Rituximab · Drug: obinutuzumab
Experimental
Experimental: Phase II Expansion Cohort C2
Bcl-2 inhibitor naïve CLL/SLL patients
Drug: MS-553 · Drug: venetoclax · Drug: Rituximab · Drug: obinutuzumab

Interventions

DrugMS-553
Oral, multiple dose levels
DrugMS-553
Oral recommended phase 2 dose of MS-553
Drugacalabrutinib
Oral
Drugvenetoclax
Oral
Also known as: Venclexta, Venclyxto
DrugRituximab
IV
Also known as: Rituxan, MabThera
Drugobinutuzumab
IV
Also known as: Gazyva

What researchers measure

Primary outcomes

The Incidence Rate of DLT and TEAE Requiring Study Drug Discontinuation
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
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.

Secondary outcomes

The ORR of MS-553 in Patients With CLL/SLL Whose Disease Relapsed After or Was Refractory to at Least One Prior Therapy
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.
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.

Results

Posted Apr 10, 2025

Participant flow

Participants enrolled between May 2018 and Oct. 2023

DLT Evaluation Period

Participant flow — DLT Evaluation Period
Milestone	Phase I Dose Escalation Cohort A1 (MS-553:100 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID)	Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort B1 (MS: 553: 200 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)
Started	4	3	3	4	4	3	3	3	4
Completed	3	3	3	3	3	3	3	3	3
Not completed	1	0	0	1	1	0	0	0	1

Dose Expansion Period

Participant flow — Dose Expansion Period
Milestone	Phase II Expansion Cohort A2 (MS-553 Monotherapy)	Phase II Expansion Cohort A3 (MS-553 Monotherapy)
Started	23	6
Completed	20	5
Not completed	3	1

Outcome measures

PrimaryThe Incidence Rate of DLT and TEAE Requiring Study Drug Discontinuation

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

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.
Reported as:: Count of participants · Participants

The Incidence Rate of DLT and TEAE Requiring Study Drug Discontinuation
Participants	Phase I Dose Escalation Cohort A1 (MS-553: 100mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 200mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 250mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 300mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 350mg BID)	Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort B1 (MS-553-200 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)
Number of participants with DLT	0	0	0	0	1	0	0	0	1
Number of participants with TEAE	0	0	0	0	1	0	0	0	1

SecondaryThe ORR of MS-553 in Patients With CLL/SLL Whose Disease Relapsed After or Was Refractory to at Least One Prior Therapy

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.

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.
Reported as:: Number · percentage of participants

The ORR of MS-553 in Patients With CLL/SLL Whose Disease Relapsed After or Was Refractory to at Least One Prior Therapy
percentage of participants	Cohort A1 (MS-553: 100 mg BID)	Cohort A1 (MS-553: 200 mg BID)	Cohort A1 (MS-553: 250 mg BID)	Cohort A1 (MS-553: 300 mg BID)	Cohort A1 (MS-553: 350 mg BID)	Cohort A2 (MS-553 Monotherapy)	Cohort A3 (MS-553 Monotherapy)	Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort B1 (MS-553: 200 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)
The ORR of MS-553 in Patients With CLL/SLL Whose Disease Relapsed After or Was Refractory to at Least One Prior Therapy	0	33.3	100	66.7	33.3	42.10	25	100	66.7	100	100

Adverse events

Collected over For the duration of the study drug treatment (up to 3 years). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Phase I Dose Escalation Cohort A1 (MS-553: 100 mg BID)	1/4 (25%)	2/4 (50%)	4/4 (100%)
Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID)	2/3 (66.7%)	3/3 (100%)	3/3 (100%)
Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID)	1/3 (33.3%)	1/3 (33.3%)	3/3 (100%)
Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID)	2/4 (50%)	3/4 (75%)	4/4 (100%)
Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID)	2/4 (50%)	3/4 (75%)	4/4 (100%)
Phase II Expansion Cohort A2 (MS-553 Monotherapy)	6/23 (26.1%)	15/23 (65.2%)	23/23 (100%)
Phase II Expansion Cohort A3 (MS-553 Monotherapy)	3/6 (50%)	3/6 (50%)	6/6 (100%)
Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)	0/3 (0%)	1/3 (33.3%)	3/3 (100%)
Phase I Combination Dose Escalation Cohort B1 (MS-553: 200 mg BID)	0/3 (0%)	2/3 (66.7%)	3/3 (100%)
Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)	0/3 (0%)	2/3 (66.7%)	3/3 (100%)
Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)	0/4 (0%)	2/4 (50%)	4/4 (100%)

Most frequent serious events

Showing 10 of 55

Most frequent serious events
Event	Phase I Dose Escalation Cohort A1 (MS-553: 100 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID)	Phase II Expansion Cohort A2 (MS-553 Monotherapy)	Phase II Expansion Cohort A3 (MS-553 Monotherapy)	Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort B1 (MS-553: 200 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)
Lung infectionInfections and infestations	0/4	0/3	0/3	0/4	2/4	1/23	0/6	0/3	1/3	0/3	0/4
Acute kidney injuryRenal and urinary disorders	2/4	0/3	0/3	1/4	1/4	0/23	0/6	0/3	0/3	1/3	0/4
ThrombocytopeniaBlood and lymphatic system disorders	0/4	0/3	1/3	0/4	0/4	0/23	0/6	0/3	0/3	0/3	0/4
Cardiac failureCardiac disorders	0/4	1/3	0/3	0/4	0/4	1/23	0/6	0/3	0/3	0/3	0/4
Myocardial infarctionCardiac disorders	0/4	0/3	1/3	0/4	0/4	0/23	0/6	0/3	0/3	1/3	0/4
PyrexiaGeneral disorders	0/4	0/3	1/3	1/4	1/4	3/23	0/6	0/3	0/3	0/3	1/4
Disease progressionGeneral disorders	0/4	0/3	0/3	0/4	0/4	0/23	0/6	0/3	1/3	0/3	0/4
CholecystitisHepatobiliary disorders	0/4	0/3	0/3	0/4	0/4	0/23	0/6	0/3	0/3	1/3	0/4
Cholecystitis acuteHepatobiliary disorders	0/4	0/3	0/3	0/4	0/4	0/23	0/6	0/3	0/3	1/3	0/4
PneumoniaInfections and infestations	1/4	1/3	1/3	0/4	0/4	2/23	0/6	0/3	0/3	0/3	0/4

Most frequent other events

Showing 10 of 184

Most frequent other events
Event	Phase I Dose Escalation Cohort A1 (MS-553: 100 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID)	Phase II Expansion Cohort A2 (MS-553 Monotherapy)	Phase II Expansion Cohort A3 (MS-553 Monotherapy)	Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort B1 (MS-553: 200 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)
Anaemias NECBlood and lymphatic system disorders	4/4	3/3	0/3	0/4	3/4	5/23	0/6	0/3	2/3	0/3	1/4
Visual disorders NECEye disorders	0/4	1/3	0/3	1/4	2/4	5/23	1/6	1/3	3/3	0/3	2/4
Diarrhoea (excl infective)Gastrointestinal disorders	2/4	2/3	3/3	2/4	4/4	11/23	3/6	2/3	1/3	1/3	2/4
Nausea and vomiting symptomsGastrointestinal disorders	4/4	2/3	3/3	2/4	3/4	17/23	2/6	2/3	3/3	2/3	4/4
Asthenic conditionsGeneral disorders	2/4	1/3	3/3	2/4	3/4	11/23	1/6	2/3	2/3	2/3	3/4
Platelet analysesInvestigations	4/4	2/3	2/3	2/4	2/4	4/23	1/6	0/3	1/3	0/3	2/4
White blood cell analysesInvestigations	4/4	2/3	2/3	1/4	4/4	6/23	1/6	0/3	1/3	0/3	2/4
Hyperglycaemic conditions NECMetabolism and nutrition disorders	4/4	2/3	1/3	0/4	3/4	2/23	0/6	1/3	1/3	0/3	1/4
Protein metabolism disorders NECMetabolism and nutrition disorders	4/4	1/3	0/3	0/4	2/4	2/23	0/6	0/3	1/3	0/3	0/4
Sodium imbalanceMetabolism and nutrition disorders	1/4	3/3	0/3	0/4	3/4	1/23	0/6	0/3	1/3	0/3	1/4

Baseline characteristics

Treated population included all participants who had received at least one dose of the study drug

Age, Categorical
Age, Categorical(Participants)	Phase I Dose Escalation Cohort A1 (MS-553: 100 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID)	Phase II Expansion Cohort A2 (MS-553 Monotherapy)	Phase II Expansion Cohort A3 (MS-553 Monotherapy)	Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort B1 (MS-553:200 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)	Total
<=18 years	0	0	0	0	0	0	0	0	0	0	0	0
Between 18 and 65 years	1	1	1	1	0	2	2	1	0	1	2	12
>=65 years	3	2	2	3	4	21	4	2	3	2	2	48

Sex: Female, Male
Sex: Female, Male(Participants)	Phase I Dose Escalation Cohort A1 (MS-553: 100 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID)	Phase II Expansion Cohort A2 (MS-553 Monotherapy)	Phase II Expansion Cohort A3 (MS-553 Monotherapy)	Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort B1 (MS-553:200 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)	Total
Female	2	1	0	1	3	8	1	1	2	0	2	21
Male	2	2	3	3	1	15	5	2	1	3	2	39

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Phase I Dose Escalation Cohort A1 (MS-553: 100 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID)	Phase II Expansion Cohort A2 (MS-553 Monotherapy)	Phase II Expansion Cohort A3 (MS-553 Monotherapy)	Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort B1 (MS-553:200 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)	Total
Hispanic or Latino	0	0	0	0	0	0	0	0	1	1	1	3
Not Hispanic or Latino	4	3	2	4	4	23	6	3	2	2	3	56
Unknown or Not Reported	0	0	1	0	0	0	0	0	0	0	0	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Phase I Dose Escalation Cohort A1 (MS-553: 100 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID)	Phase II Expansion Cohort A2 (MS-553 Monotherapy)	Phase II Expansion Cohort A3 (MS-553 Monotherapy)	Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort B1 (MS-553:200 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0	0
Asian	0	0	0	0	0	0	0	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0	0
Black or African American	0	0	0	1	0	0	0	0	0	0	0	1
White	4	3	2	3	4	23	6	3	2	3	4	57
More than one race	0	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	1	0	0	0	0	0	1	0	0	2

Region of Enrollment
Region of Enrollment(participants)	Phase I Dose Escalation Cohort A1 (MS-553: 100 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID)	Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID)	Phase II Expansion Cohort A2 (MS-553 Monotherapy)	Phase II Expansion Cohort A3 (MS-553 Monotherapy)	Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort B1 (MS-553:200 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)	Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)	Total
United States	4	3	3	4	4	23	6	3	3	3	4	60

Study locations

5 sites

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

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Jun 16, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from May 2018 to primary completion in Nov 2023, 66 months.

Results were first posted in Apr 2025, 1 year 4 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 24, 2018
First posted: Apr 10, 2018
StartActual: May 25, 2018
Primary completionActual: Nov 28, 2023
CompletionActual: Nov 28, 2023
Results first posted: Apr 10, 2025
Last update: Apr 10, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03492125
Lead sponsor: MingSight Pharmaceuticals, Inc
Responsible party: Sponsor
First posted: Apr 10, 2018
Start date: May 25, 2018
Primary completion: Nov 28, 2023
Completion: Nov 28, 2023
Results posted: Apr 10, 2025
Last update: Apr 10, 2025

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: PKC-beta Inhibitor MS-553

Other studies in this condition

Leukemia, Lymphocytic, Chronic, B-Cell →

Other studies from this sponsor

MingSight Pharmaceuticals, Inc

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