Back to resultsA Clinical Study of 6MW3211 Injection in the Treatment of Relapsed/Refractory Lymphoma
Primary Purpose
Lymphoma
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
6MW3211
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Voluntarily participate in the study and sign the informed consent.
- Age≥18 years.
- Subjects with relapsed or refractory lymphoma.
- Subjects with at least one measurable tumor lesion.
- ECOG 0-2.
- Life expectancy≥3 months.
- Adequate organ functions.
Exclusion Criteria:
- Subjects who had received anticancer therapy or radiotherapy within 21 days or 5 half-lives (whichever is shorter) before enrollment or received adoptive cellular immunotherapy within 12 weeks.
- Subjects who had received allogeneic hematopoietic stem cell transplantation or organ transplantation or received autologous hematopoietic stem cell transplantation within 3 months.
- Subjects with primary or secondary CNS lymphoma.
- History of another malignancy within 3 years before the first dose of investigational drug.
- History of active autoimmune diseases.
- Systemic immunosuppressive therapy within 2 weeks prior to the first dose of investigational drug.
- Subjects who experienced grade 3 or above immune-related adverse events (irAE) .
- Documented history of uncontrolled systemic diseases.
- Subjects who were allergic to any composition of investigational drug.
- Major surgery within 28 days prior to first dose of investigational drug.
- Subjects with active infection.
- Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).
- Subjects with poor treatment compliance.
- Use of any investigational drug or device within 28 days prior to the first dose of investigational drug.
- Live vaccine was administered within 28 days prior to first dose of investigational drug.
- Pregnant or lactating women.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
6MW3211
Arm Description
6MW3211 injection, 45mg/kg, Q2W
Outcomes
Primary Outcome Measures
Objective response rate
Defined as the percentage of subjects who experience a best response of either CR or PR
Secondary Outcome Measures
Complete response rate
Defined as the percentage of subjects who experience a best response of CR
Duration of response
Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause
Time to response
Time from the date of first infusion to the date of confirmed CR or PR
Progression free survival
Time from the date of first infusion to the earliest date of documented disease progression per radiological evidence or death from any cause
Overall survival
Time from the date of first infusion until the date of death from any cause
Incidence of adverse events
PK Parameter
Maximum concentration (Cmax)
Full Information
NCT ID
NCT05446688
First Posted
June 27, 2022
Last Updated
July 2, 2022
Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05446688
Brief Title
A Clinical Study of 6MW3211 Injection in the Treatment of Relapsed/Refractory Lymphoma
Official Title
A Phase 2, Multicenter, Non-Randomized, Open-Label, Single-Arm Study to Evaluate the Preliminary Efficacy and Safety of 6MW3211 in Patients With Relapsed or Refractory Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a single arm, non-randomized, open label phase 2 international, multicenter clinical trial to evaluate preliminary efficacy and safety in subjects with relapsed or refractory lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
6MW3211
Arm Type
Experimental
Arm Description
6MW3211 injection, 45mg/kg, Q2W
Intervention Type
Drug
Intervention Name(s)
6MW3211
Intervention Description
6MW3211 injection, 45mg/kg, Q2W
Primary Outcome Measure Information:
Title
Objective response rate
Description
Defined as the percentage of subjects who experience a best response of either CR or PR
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Complete response rate
Description
Defined as the percentage of subjects who experience a best response of CR
Time Frame
1 Year
Title
Duration of response
Description
Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause
Time Frame
1 Year
Title
Time to response
Description
Time from the date of first infusion to the date of confirmed CR or PR
Time Frame
1 Year
Title
Progression free survival
Description
Time from the date of first infusion to the earliest date of documented disease progression per radiological evidence or death from any cause
Time Frame
1 Year
Title
Overall survival
Description
Time from the date of first infusion until the date of death from any cause
Time Frame
1 Year
Title
Incidence of adverse events
Time Frame
Up to 28 days post last dose
Title
PK Parameter
Description
Maximum concentration (Cmax)
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntarily participate in the study and sign the informed consent.
Age≥18 years.
Subjects with relapsed or refractory lymphoma.
Subjects with at least one measurable tumor lesion.
ECOG 0-2.
Life expectancy≥3 months.
Adequate organ functions.
Exclusion Criteria:
Subjects who had received anticancer therapy or radiotherapy within 21 days or 5 half-lives (whichever is shorter) before enrollment or received adoptive cellular immunotherapy within 12 weeks.
Subjects who had received allogeneic hematopoietic stem cell transplantation or organ transplantation or received autologous hematopoietic stem cell transplantation within 3 months.
Subjects with primary or secondary CNS lymphoma.
History of another malignancy within 3 years before the first dose of investigational drug.
History of active autoimmune diseases.
Systemic immunosuppressive therapy within 2 weeks prior to the first dose of investigational drug.
Subjects who experienced grade 3 or above immune-related adverse events (irAE) .
Documented history of uncontrolled systemic diseases.
Subjects who were allergic to any composition of investigational drug.
Major surgery within 28 days prior to first dose of investigational drug.
Subjects with active infection.
Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).
Subjects with poor treatment compliance.
Use of any investigational drug or device within 28 days prior to the first dose of investigational drug.
Live vaccine was administered within 28 days prior to first dose of investigational drug.
Pregnant or lactating women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Zhao, Doctor
Phone
021-64370045
Email
zwl_trail@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saijuan Chen, Doctor
Organizational Affiliation
Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weili Zhao, Doctor
Organizational Affiliation
Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of 6MW3211 Injection in the Treatment of Relapsed/Refractory Lymphoma
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