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Protein Kinase Inhibitor
MS-553 for Chronic Lymphocytic Leukemia
Phase 1 & 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day1, cycle 1 day 8, (each cycle is 28 days)
Awards & highlights
Study Summary
This trial is testing a new drug for people with CLL/SLL. The drug is designed to kill cancer cells by targeting a protein called PKC-beta.
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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with CLL or SLL and need treatment according to 2008 guidelines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 day1, cycle 1 day 8, (each cycle is 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day1, cycle 1 day 8, (each cycle is 28 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 outcome measures
Chronic Lymphocytic Leukemia
Evaluate pharmacogenomic biomarkers in patients with CLL/SLL treated with MS-553 to compare germline DNA with tumor DNA via changes in sequence analysis
Pharmacokinetic (PK) parameters of MS-553
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
Find a Location
Who is running the clinical trial?
MingSight Pharmaceuticals, Inc.Lead Sponsor
MingSight Pharmaceuticals, IncLead Sponsor
1 Previous Clinical Trials
38 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My CLL/SLL has transformed into a more aggressive form of cancer.I have an active autoimmune condition affecting my blood cells.I am 18 years old or older.I haven't had major surgery, high-dose steroids, or certain cancer treatments in the last 14 days.I have been diagnosed with CLL or SLL and need treatment according to 2008 guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I Combination Dose Escalation Cohort C1
- Group 2: Experimental: Phase II Expansion Cohort C2
- Group 3: Phase II Expansion Cohort A2 (MS-553 Monotherapy)
- Group 4: Phase I Combination Dose Escalation Cohort B1
- Group 5: Phase II Expansion Cohort A3 (MS-553 Monotherapy)
- Group 6: Phase I Dose Escalation Cohort A1 (MS-553 Monotherapy)
- Group 7: Phase II Expansion Cohort B2
- Group 8: Phase II Expansion Cohort B3
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many physical sites are involved in the oversight of this trial?
"The Huntsman Cancer Institute in Salt Lake City, Utah; MD Anderson Cancer Center's Department of Leukemia in Houston, Texas; and The Ohio State University’s James Comprehensive Cancer Centre located in Columbus, Ohio are the three main sites for this trial. Additionally, there are five other locations participating."
Answered by AI
Are there still vacancies for participants in this experiment?
"Affirmative. Clinicaltrials.gov verifies that this experiment is actively recruiting participants, first advertised on May 25th 2018 and most recently updated November 17 2022. 117 volunteers are needed to be enrolled at 5 different medical centres."
Answered by AI
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