Lymphoma
Conditions
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.
Interventions
DRUG6MW3211
6MW3211 injection, 45mg/kg, Q2W
Sponsors
Mabwell (Shanghai) Bioscience Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 1 Year | Defined as the percentage of subjects who experience a best response of either CR or PR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response | 1 Year | 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 | 1 Year | Time from the date of first infusion to the date of confirmed CR or PR |
| Progression free survival | 1 Year | Time from the date of first infusion to the earliest date of documented disease progression per radiological evidence or death from any cause |
| Complete response rate | 1 Year | Defined as the percentage of subjects who experience a best response of CR |
| Incidence of adverse events | Up to 28 days post last dose | — |
| PK Parameter | 1 Year | Maximum concentration (Cmax) |
| Overall survival | 1 Year | Time from the date of first infusion until the date of death from any cause |
Contacts
Primary ContactWeili Zhao, Doctor
Outcome results
None listed