Clinical trial NCT05446688: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective response rate
timeFrame: 1 Year
Secondary outcomes:
measure: Complete response rate
timeFrame: 1 Year
measure: Duration of response
timeFrame: 1 Year
measure: Time to response
timeFrame: 1 Year
measure: Progression free survival
timeFrame: 1 Year
measure: Overall survival
timeFrame: 1 Year
measure: Incidence of adverse events
timeFrame: Up to 28 days post last dose
measure: PK Parameter
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
affiliation: Ruijin Hospital
name: Saijuan Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Weili Zhao, Doctor
role: PRINCIPAL_INVESTIGATOR
References: