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Relapsed or Refractory B-cell LymphomaPhase 1/2NCT05720052

A Study of MS-553 in Patients With Relapsed or Refractory B-cell Lymphoma

A Phase 1/2 study testing MS-553 in people with Relapsed or Refractory B-cell Lymphoma and Diffuse Large B-cell Lymphoma (DLBCL), run by MingSight Pharmaceuticals, Inc at 1 site in China.

Terminated

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

Official record
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Trial summary

This is a Phase I/II, single-arm, multicenter, open-label study which is divided into two portions: Phase I is dose escalation portion, in which subjects with relapsed or refractory B-cell lymphoma will be enrolled except malignant lymphoblastic lymphoma (LBL) and Burkitt lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MS-553
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteChina
Study dates
6 Feb 2023to 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

  • 1) Patients in Phase I study will be enrolled with refractory or relapsed B-cell non-Hodgkin lymphoma.
  • 2) Patients enrolled in the phase I study failed two or more lines of treatment regimens; Patients with mantle cell lymphoma should also be patients with contraindications or failure of BTK inhibitor therapy.
  • 3) Eastern Cooperative Oncology Group (ECOG) performance status score is 0~2.
  • 4) Have life expectancy ≥ 3 months.
  • 5) Major organ functions meet the following criteria:
  • In the absence of growth factor support therapy or blood transfusion in the last 14 days: absolute neutrophil count ≥1.5×109/L, hemoglobin ≥80 g/L, platelets ≥75×109/L (no platelet transfusion within 14 days); if accompanied with bone marrow invasion, neutrophils ≥1.0×109/L, platelets ≥50×109/L.
  • Biochemistry: Total bilirubin ≤1.5×ULN or ≤3.0×ULN in Gilbert's syndrome, AST or ALT ≤2.5×ULN, serum creatinine ≤1.5×ULN or calculated creatinine clearance ≥60 mL/min (Cockcroft-Gault formula).
  • Coagulation function: International normalized ratio (INR) and activated partial thrombin time ≤ 1.5 × ULN.

Who cannot join

  • 1) Present or prior history of other malignancies (except cured carcinoma in situ of cervix and basal cell carcinoma of skin), unless there is radical treatment and no evidence of recurrence or metastasis within the last 2 years.
  • 2) Lymphomas involved the central nervous system.
  • 3) Patients with history of organ transplantation or allogeneic hematopoietic stem cell transplantation; patients who have received autologous hematopoietic stem cell transplantation or CAR-T treatment within the past 3 months,
  • 4) Patients who are suitable and ready for autologous stem cell transplantation.
  • 5) History of eye surgery or trauma within 3 months before the screening visit, history of serious eye infection or the most recent eye surgery within 4 weeks before the screening visit.
  • 6) Has had active and uncontrolled autoimmune hemocytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.
Show all 11Show fewer
  • 7) Has had uncontrolled or significant cardiovascular diseases, including:
  • 8) Women who are lactating or pregnant.
  • 9) Women of child-bearing potential who do not agree to have two pregnancy tests prior to first dose (at least one of tests is serum pregnancy test) and the test result shall be negative.
  • 10) Male patients who do not agree to the birth control measures.
  • 11) Any conditions that in the opinion of the investigator considers inappropriate to participate in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing

Other trials in China

About this study

Official title: A Phase I/II Study to Evaluate the Safety and Efficacy of the MS-553 in Patients With Relapsed or Refractory B-cell Lymphoma

This is a Phase I/II, single-arm, multicenter, open-label study which is divided into two portions: Phase I is dose escalation portion, in which subjects with relapsed or refractory B-cell lymphoma will be enrolled except malignant lymphoblastic lymphoma (LBL) and Burkitt lymphoma. After the RP2D is identified, Phase II of subjects with relapsed or refractory mantle cell lymphoma who previously received ≥ 2 and ≤ 4 different chemotherapy and/or targeted drug therapy will be enrolled.

Being tested
MS-553
Medical subject headings
Recurrence, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MS-553Drug

    MS-553 oral tablet BID x 28-days

Study groups in NCT05720052
Study groupRoleWhat they receive
Single armExperimentaldose exploration
Receives: Drug: MS-553

What is being measured

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

  1. Incidence of dose limiting toxicity (DLT)

    Measured: First cycle (28 days)

  2. Incidence and severity of adverse events

    Measured: up to 24 months

  3. To determine the MTD and RP2D of oral MS-553 in patients with BCL

    Measured: about 8 months

Secondary outcomes (11)

  1. Objective response rate (ORR)

    Measured: up to 24 months

  2. Duration of response (DOR)

    Measured: up to 24 months

  3. progression-free survival (PFS)

    Measured: up to 24 months

  4. overall survival (OS)

    Measured: up to 24 months

  5. time to progression (TTR)

    Measured: up to 24 months

  6. disease control rate (DCR)

    Measured: up to 24 months

  7. Pharmacokinetics parameters: Cmax

    Measured: within the first 2 cycles (56 days)

  8. Pharmacokinetics parameters: Tmax

    Measured: within the first 2 cycles (56 days)

  9. Pharmacokinetics parameters: T1/2

    Measured: within the first 2 cycles (56 days)

  10. Pharmacokinetics parameters: AUC0-12

    Measured: within the first 2 cycles (56 days)

  11. Pharmacokinetics parameters: CL/F

    Measured: within the first 2 cycles (56 days)

Timeline

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

  1. First posted9 Feb 2023
  2. Study start6 Feb 2023
  3. Primary completion28 Nov 2023
  4. Study completion28 Nov 2023

Why it stopped: The study is terminated due to major protocol revisions.

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05720052
Sponsor's protocol ID
2020-003-CN
Status last verified
Jul 2024
First submitted
11 Jan 2023
Last updated
18 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MS-553 in people with Relapsed or Refractory B-cell Lymphoma and Diffuse Large B-cell Lymphoma (DLBCL), run by MingSight Pharmaceuticals, Inc 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 8 inclusion and 11 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 toxicity (DLT) (time frame: First cycle (28 days)). The study lists 3 primary outcomes in all. 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 NCT05720052.

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.

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