AzTrials
AzTrials

Chronic Lymphocytic LeukemiaPhase 1/2NCT03492125

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

A Phase 1/2 study testing MS-553, acalabrutinib and venetoclax in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by MingSight Pharmaceuticals, Inc at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MS-553, acalabrutinib and venetoclax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
5 sitesUnited States
Study dates
25 May 2018to 28 Nov 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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)
  • 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)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University Of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • The Ohio State University, James Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • MD Anderson Cancer Center, Department of Leukemia

    Houston, Texas, 77030

  • Columbia University, Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

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

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

Being tested
MS-553, acalabrutinib, venetoclax, Rituximab, obinutuzumab
Medical subject headings
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-553Drug

    Oral, multiple dose levels

  • MS-553Drug

    Oral recommended phase 2 dose of MS-553

  • acalabrutinibDrug

    Oral

  • venetoclaxDrug

    Also called Venclexta, Venclyxto

    Oral

  • RituximabDrug

    Also called Rituxan, MabThera

    IV

  • obinutuzumabDrug

    Also called Gazyva

    IV

Study groups in NCT03492125
Study groupRoleWhat they receive
Phase I Dose Escalation Cohort A1 (MS-553 Monotherapy)ExperimentalR/R CLL/SLL patients
Receives: Drug: MS-553
Phase II Expansion Cohort A2 (MS-553 Monotherapy)ExperimentalR/R CLL/SLL patients
Receives: Drug: MS-553
Phase II Expansion Cohort A3 (MS-553 Monotherapy)Experimentalpatients with aggressive lymphoma
Receives: Drug: MS-553
Phase I Combination Dose Escalation Cohort B1ExperimentalBTK inhibitor naïve CLL/SLL patients
Receives: Drug: MS-553; Drug: acalabrutinib
Phase II Expansion Cohort B2ExperimentalBTK inhibitor naïve CLL/SLL patients
Receives: Drug: MS-553; Drug: acalabrutinib
Phase II Expansion Cohort B3ExperimentalBTK inhibitor naïve CLL/SLL patients with certain gene mutations
Receives: Drug: MS-553; Drug: acalabrutinib
Phase I Combination Dose Escalation Cohort C1ExperimentalBcl-2 inhibitor naïve CLL/SLL patients
Receives: Drug: MS-553; Drug: venetoclax; Drug: Rituximab; Drug: obinutuzumab
Experimental: Phase II Expansion Cohort C2ExperimentalBcl-2 inhibitor naïve CLL/SLL patients
Receives: Drug: MS-553; Drug: venetoclax; Drug: Rituximab; Drug: obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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 (1)

  1. 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.

    Measured: Evaluation of the efficacy endpoints related to response will incorporate the data from the first 9 cycles (up to 252 days) of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2018
  2. Study start25 May 2018
  3. Primary completion28 Nov 2023
  4. Study completion28 Nov 2023

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

Resources

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
Single group
Model description
a limited 3+3 phase 1 dose escalation study with expansion cohorts
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03492125
Sponsor's protocol ID
MS-553-103
Status last verified
Apr 2025
First submitted
24 Mar 2018
Last updated
10 Apr 2025
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MS-553, acalabrutinib and venetoclax in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by MingSight Pharmaceuticals, Inc at 5 sites in United States.

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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 10 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03492125.

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 10 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in