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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Lymphoma
• Intervention / Treatment: Drug: 6MW3211

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Weili Zhao, Doctor; Phone Number: 021-64370045; Email: zwl_trail@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 6MW3211; 6MW3211 injection, 45mg/kg, Q2W	Drug: 6MW3211; 6MW3211 injection, 45mg/kg, Q2W

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
• Investigators: Principal Investigator: Saijuan Chen, Doctor, Ruijin hospital, school of medicine, Shanghai jiao tong university; Principal Investigator: Weili Zhao, Doctor, Ruijin hospital, school of medicine, Shanghai jiao tong university

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: July 2, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 2, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: 6MW3211-2022-CP201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No