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

NCT ID: NCT05446688

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-09-01

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

6MW3211

6MW3211 injection, 45mg/kg, Q2W

Group Type: EXPERIMENTAL

6MW3211

Intervention Type: DRUG

6MW3211 injection, 45mg/kg, Q2W

Interventions

6MW3211

6MW3211 injection, 45mg/kg, Q2W

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mabwell (Shanghai) Bioscience Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saijuan Chen, Doctor

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Weili Zhao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Central Contacts

Weili Zhao, Doctor

Role: CONTACT

zwl_trail@163.com

021-64370045

Other Identifiers

6MW3211-2022-CP201

Identifier Type: -

Identifier Source: org_study_id