Lymphocytic LeukemiaPhase 1/2NCT05272813
A Study to Investigate the Efficacy and Safety of MS-553 in CLL/SLL
A Phase 1/2 study testing MS-553 in people with Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Shenzhen MingSight Relin Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is a Phase I/II, single arm, multi-center, open-label clinical trial of MS-553 in patients with CLL/SLL whose disease relapsed after or was refractory to at lease 1 prior therapy (chemotherapy and/or targeted drug therapy, which must include BTK inhibitor therapy) and who are indicated for treatment per IWCLL2018. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- MS-553
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2022to 28 Nov 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Age 18 years or older, male or female.
- Diagnosis of CLL/SLL per IWCLL2018 criteria.
- Patients with relapsed or refractory CLL/SLL who have failed at least 1 prior therapy (chemotherapy and/or targeted drug therapy, which must include BTK inhibitor therapy), are indicated for treatment per IWCLL2018.
- Measurable lesions detected by contrast-enhanced computed tomography (CT): at least one lymph node with a maximum axis of more than 1.5 cm and one measurable vertical dimension.
- WHO/ECOG performance status of 0 to 2.
- Patients with an estimated survival of more than 3 months.
Who cannot join
- Biopsy-proven and pathologically confirmed current or past transformation to Richter's syndrome.
- Patients with active and uncontrolled autoimmune cytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.
- Patients who have received any of the following treatments within 14 days prior to the first dose:
- Major surgery;
- Glucocorticoids (at a dose equal to or greater than 20 mg/day prednisone or equivalent), unless used by inhalation, topical or intraarticular route, or unless necessary for premedication before and after iodinated contrast dye. After discussion with the Sponsor, steroid therapy at high doses for an extended period may be allowed under the following circumstances:
- Treatment of autoimmune hemolysis or autoimmune thrombocytopenia associated with CLL/SLL;
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- Short-term (within 14 days) use to treat inactive infections of diseases unrelated to CLL/SLL (e.g. arthritis, asthma), which results in acute exacerbation, including steroid dose modifications required for adrenal insufficiency;
- Cytotoxic chemotherapy or biologic therapy, excepting BCR pathway kinase inhibitors for which a washout of 24 hours prior to the first dose is required.
- Toxicity from prior anti-tumor therapy (chemotherapy, radiotherapy, or biotherapy) did not restore to ≤ Grade 1 (except for alopecia); atrial fibrillation from prior treatment with BTK inhibitors did not restore to ≤ Grade 2.
- Central nervous system (CNS) leukemia or lymphoma, including a history of asymptomatic, previously treated CNS disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study to Investigate the Efficacy and Safety of MS-553 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
This is a Phase I/II, single arm, multi-center, open-label clinical trial of MS-553 in patients with CLL/SLL whose disease relapsed after or was refractory to at lease 1 prior therapy (chemotherapy and/or targeted drug therapy, which must include BTK inhibitor therapy) and who are indicated for treatment per IWCLL2018.
- Conditions
- Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Being tested
- MS-553
- Medical subject headings
- Leukemia, Lymphoid, 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
MS-553
| Study group | Role | What they receive |
|---|---|---|
| MS-553 Low Dose | Experimental | MS-553 Low Dose PO BID Receives: Drug: MS-553 |
| MS-553 Mid Dose-1 | Experimental | MS-553 Mid Dose-1 PO BID Receives: Drug: MS-553 |
| MS-553 Mid Dose-2 | Experimental | MS-553 Mid Dose-2 PO BID Receives: Drug: MS-553 |
| MS-553 High Dose | Experimental | MS-553 High Dose PO BID Receives: Drug: MS-553 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities
Measured: 28 days
Secondary outcomes (7)
Incidence and severity of adverse events
Measured: Assessed throughout the study from the time of first dose of study drug until 30 days after the patient's last dose of study drug or until the event has resolved, stabilized, or an outcome reached, whichever comes first regardless of timing of EoT visit
Overall response rate
Measured: up to 24 months
Time to tumor response
Measured: During intervention
Disease control rate
Measured: During intervention
Progression free survival
Measured: During intervention
Overall survival
Measured: During intervention
Assessment of minimal residual disease
Measured: During intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start28 Apr 2022
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Why it stopped: The study is terminated due to major protocol revisions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Model description
- Stage 1 3+3 dose escalation study with expansion to Stage 2
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kai Zhang, MD, Study director, Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272813
- Sponsor's protocol ID
- 2020-001-CN
- Status last verified
- Jul 2024
- First submitted
- 18 Feb 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Investigate the Efficacy and Safety of MS-553 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- ClinicalTrials.gov ID
- NCT05272813
- Acronym / sponsor ID
- 2020-001-CN
- Conditions
- Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is terminated due to major protocol revisions.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I/II, single arm, multi-center, open-label clinical trial of MS-553 in patients with CLL/SLL whose disease relapsed after or was refractory to at lease 1 prior therapy (chemotherapy and/or targeted drug therapy, which must include BTK inhibitor therapy) and who are indicated for treatment per IWCLL2018.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Stage 1 3+3 dose escalation study with expansion to Stage 2
| Arm | Type | Receives |
|---|---|---|
| MS-553 Low Dose | Experimental | Drug: MS-553MS-553 Low Dose PO BID |
| MS-553 Mid Dose-1 | Experimental | Drug: MS-553MS-553 Mid Dose-1 PO BID |
| MS-553 Mid Dose-2 | Experimental | Drug: MS-553MS-553 Mid Dose-2 PO BID |
| MS-553 High Dose | Experimental | Drug: MS-553MS-553 High Dose PO BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older, male or female.
- Diagnosis of CLL/SLL per IWCLL2018 criteria.
- Patients with relapsed or refractory CLL/SLL who have failed at least 1 prior therapy (chemotherapy and/or targeted drug therapy, which must include BTK inhibitor therapy), are indicated for treatment per IWCLL2018.
- Measurable lesions detected by contrast-enhanced computed tomography (CT): at least one lymph node with a maximum axis of more than 1.5 cm and one measurable vertical dimension.
- WHO/ECOG performance status of 0 to 2.
Key exclusion criteria (10 listed)
- Biopsy-proven and pathologically confirmed current or past transformation to Richter's syndrome.
- Patients with active and uncontrolled autoimmune cytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.
- Patients who have received any of the following treatments within 14 days prior to the first dose:
- Toxicity from prior anti-tumor therapy (chemotherapy, radiotherapy, or biotherapy) did not restore to ≤ Grade 1 (except for alopecia); atrial fibrillation from prior treatment with BTK inhibitors did not restore to ≤ Grade 2.
- Central nervous system (CNS) leukemia or lymphoma, including a history of asymptomatic, previously treated CNS disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MS-553MS-553 | Drug | MS-553 High Dose, MS-553 Low Dose, MS-553 Mid Dose-1, MS-553 Mid Dose-2 |
Primary outcome
Incidence of dose limiting toxicities
Time frame: 28 days
7 secondary outcomes
Incidence and severity of adverse events
Time frame: Assessed throughout the study from the time of first dose of study drug until 30 days after the patient's last dose of study drug or until the event has resolved, stabilized, or an outcome reached, whichever comes first regardless of timing of EoT visit
Overall response rate
Time frame: up to 24 months
Time to tumor response
Time frame: During intervention
Disease control rate
Time frame: During intervention
Progression free survival
Time frame: During intervention
Overall survival
Time frame: During intervention
Assessment of minimal residual disease
Time frame: During intervention
Results and safety
The study was stopped early (reason given: The study is terminated due to major protocol revisions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai Zhang, MD study director
Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MS-553 in people with Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Shenzhen MingSight Relin Pharmaceuticals Co., Ltd. at 1 site in China.
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 6 inclusion and 10 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 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study was stopped early (reason given: The study is terminated due to major protocol revisions.). Results are not available in the source record.
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?
Incidence of dose limiting toxicities (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2024.