NCT05446688Not yet recruitingPhase 2
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
Mabwell (Shanghai) Bioscience Co., Ltd.0 sites40 target enrollmentStarted: September 1, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 40
- Primary Endpoint
- Objective response rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Arms & Interventions
6MW3211
Experimental
6MW3211 injection, 45mg/kg, Q2W
Intervention: 6MW3211 (Drug)
Outcomes
Primary Outcomes
Objective response rate
Time Frame: 1 Year
Defined as the percentage of subjects who experience a best response of either CR or PR
Secondary Outcomes
- Complete response rate(1 Year)
- Duration of response(1 Year)
- Time to response(1 Year)
- Progression free survival(1 Year)
- Incidence of adverse events(Up to 28 days post last dose)
- PK Parameter(1 Year)
- Overall survival(1 Year)
Investigators
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