A Clinical Study of 6MW3211 Injection in the Treatment of Relapsed/Refractory Lymphoma

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: 6MW3211


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6MW3211<br>6MW3211 injection, 45mg/kg, Q2W | Drug: 6MW3211<br>* 6MW3211 injection, 45mg/kg, Q2W<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Defined as the percentage of subjects who experience a best response of either CR or PR | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate | Defined as the percentage of subjects who experience a best response of CR | 1 Year | 
| 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 | 1 Year | 
| Time to response | Time from the date of first infusion to the date of confirmed CR or PR | 1 Year | 
| 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 | 1 Year | 
| Overall survival | Time from the date of first infusion until the date of death from any cause | 1 Year | 
| Incidence of adverse events |  | Up to 28 days post last dose | 
| PK Parameter | Maximum concentration (Cmax) | 1 Year |